Randomised intervention study to assess the prevalence of subclinical vascular disease and hidden kidney disease and its impact on morbidity and mortality: The ILERVAS project

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Proyecto ILERVAS. aaleatorizados por conglomerados (CAP) anualmente. CAP: centro de Atención Primaria; CV: cardiovascular; ERC: enfermedad renal crónica; FRCV: factor de riesgo cardiovascular; UM: unidad móvil." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Àngels Betriu, Cristina Farràs, María Abajo, Montserrat Martinez-Alonso, David Arroyo, Ferran Barbé, Miquel Buti, Albert Lecube, Manuel Portero, Francisco Purroy, Gerard Torres, José Manuel Valdivielso, Elvira Fernández" "autores" => array:13 [ 0 => array:2 [ "nombre" => "Àngels" "apellidos" => "Betriu" ] 1 => array:2 [ "nombre" => "Cristina" "apellidos" => "Farràs" ] 2 => array:2 [ "nombre" => "María" "apellidos" => "Abajo" ] 3 => array:2 [ "nombre" => "Montserrat" "apellidos" => "Martinez-Alonso" ] 4 => array:2 [ "nombre" => "David" "apellidos" => "Arroyo" ] 5 => array:2 [ "nombre" => "Ferran" "apellidos" => "Barbé" ] 6 => array:2 [ "nombre" => "Miquel" "apellidos" => "Buti" ] 7 => array:2 [ "nombre" => "Albert" "apellidos" => "Lecube" ] 8 => array:2 [ "nombre" => "Manuel" "apellidos" => "Portero" ] 9 => array:2 [ "nombre" => "Francisco" "apellidos" => "Purroy" ] 10 => array:2 [ "nombre" => "Gerard" "apellidos" => "Torres" ] 11 => array:2 [ "nombre" => "José Manuel" "apellidos" => "Valdivielso" ] 12 => array:2 [ "nombre" => "Elvira" "apellidos" => "Fernández" ] ] ] ] ] "idiomaDefecto" => "es" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2013251416300682" "doi" => "10.1016/j.nefroe.2016.07.006" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2013251416300682?idApp=UINPBA000064" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0211699516000382?idApp=UINPBA000064" "url" => "/02116995/0000003600000004/v2_201611160150/S0211699516000382/v2_201611160150/es/main.assets" ] ] "itemSiguiente" => array:20 [ "pii" => "S2013251416301006" "issn" => "20132514" "doi" => "10.1016/j.nefroe.2016.11.003" "estado" => "S300" "fechaPublicacion" => "2016-07-01" "aid" => "136" "copyright" => "Sociedad Española de Nefrología" "documento" => "article" "crossmark" => 0 "licencia" => "http://creativecommons.org/licenses/by-nc-nd/4.0/" "subdocumento" => "fla" "cita" => "Nefrologia (English Version). 2016;36:397-403" "abierto" => array:3 [ "ES" => true "ES2" => true "LATM" => true ] "gratuito" => true "lecturas" => array:2 [ "total" => 5135 "formatos" => array:3 [ "EPUB" => 334 "HTML" => 3946 "PDF" => 855 ] ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "Original article" "titulo" => "The neutrophil–lymphocyte ratio as a marker of systemic endothelial dysfunction in asymptomatic subjects" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "397" "paginaFinal" => "403" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "El índice neutrófilo/linfocito como marcador de disfunción sistémica endotelial en sujetos asintomáticos" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1145 "Ancho" => 1369 "Tamanyo" => 60853 ] ] "descripcion" => array:1 [ "en" => "Distribution of abnormal UACR in different NLR groups. 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"fn0005" ] 4 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:13 [ 0 => array:3 [ "entidad" => "Institut de Recerca Biomèdica (IRBLleida), Lérida, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Diagnóstico y Tratamiento Enfermedades Aterotrombóticas (UDETMA), Servicio de Nefrología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Área Básica de Salut Borges Blanques, Lérida, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Departamento Bioestadística, IRBLleida, Lérida, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Servicio de Nefrología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Servicio de Neumología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain" "etiqueta" => "g" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Dirección de Atención Primaria, Lérida, Spain" "etiqueta" => "h" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Servicio de Endocrinología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "etiqueta" => "i" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Grupo de Fisiopatología Metabólica, Departamento de Medicina Experimental, IRBLleida, Lérida, Spain" "etiqueta" => "j" "identificador" => "aff0050" ] 10 => array:3 [ "entidad" => "Servicio de Neurología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "etiqueta" => "k" "identificador" => "aff0055" ] 11 => array:3 [ "entidad" => "Servicio de Medicina Interna, Hospital Universitari de Santa María, Lérida, Spain" "etiqueta" => "l" "identificador" => "aff0060" ] 12 => array:3 [ "entidad" => "Laboratorio de Nefrología Experimental, IRBLleida, Lérida, Spain" "etiqueta" => "m" "identificador" => "aff0065" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Estudio de intervención aleatorizado para evaluar la prevalencia de enfermedad ateromatosa y renal ocultas y su impacto en la morbimortalidad: Proyecto ILERVAS" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1789 "Ancho" => 2503 "Tamanyo" => 395058 ] ] "descripcion" => array:1 [ "en" => "Population selection diagram for the ILERVAS project. a Randomised by cluster (CAP) annually. CAP: primary care centre; CV: cardiovascular; CKD: chronic kidney disease; CVRF: cardiovascular risk factor; MU: mobile unit." ] ] ] "textoCompleto" => "IntroductionCardiovascular (CV) diseases are the leading cause of morbidity and mortality worldwide, with a major social, healthcare-related and economic impact. In 2012, in the European Union, CV disease accounted for 40% of overall mortality with a cost of €196billion, distributed as follows: 54% for healthcare spending, 24% for lost productivity and 22% for care of patients with CV disease.<a class="elsevierStyleCrossRef" href="#bib0160">1</a> In the same year, in Spain, CV disease accounted for 30% of all recorded deaths and 15% of all hospital admissions.<a class="elsevierStyleCrossRef" href="#bib0165">2</a> In the Spanish province of Lleida, in 2012, CV disease was the leading cause of death, with a prevalence of 26% of ischaemic heart disease of and 27%.of cerebrovascular events.<a class="elsevierStyleCrossRef" href="#bib0170">3</a>Risk calculation tables (Framingham, Score, Regicor) based on traditional CV risk factors such as age, sex, smoking habit, blood pressure, total cholesterol and diabetes have been used to detect the population susceptible of having a CV event. However, these calculations do not take into account other factors that also have an impact. These factors include, but are not limited to a history of early CV disease in first-degree relatives (men before age 55, women before age 65), genetic factors and individual susceptibility, obesity, socioeconomic level, sleep apnoea, and chronic kidney disease (CKD). It has been indicated that more than 60% of CV events occur in individuals with a low to moderate calculated risk, and that 4 of every 10 cases of miocardial infarction or sudden death occur in people with no prior history of CV disease.<a class="elsevierStyleCrossRef" href="#bib0175">4</a>Numerous population studies, based on large cohorts and long periods of follow-up, have demonstrated a clear association between the presence of an atheromatous plaque in the carotid arteries and the risk of having a coronary or cerebrovascular event (1.8–4.1, respectively), and have concluded that a diagnosis of subclinical atheromatosis increases the predictive value of traditional risk equations, which reclassify individuals according to degrees of risk greater than those calculated by these algorithms.<a class="elsevierStyleCrossRefs" href="#bib0180">5–9</a>Atheromatous disease is characterised by a chronic, proliferative and multifactorial inflammatory process that affects the vascular bed such that atheromatous plaques form in medium- to large-sized arteries walls (carotid, femoral, cerebral, coronary and renal).<a class="elsevierStyleCrossRef" href="#bib0205">10</a> The clinical manifestations will depend on both the area and the number of vascular regions affected, and on the volume and vulnerability of the atheromatous plaque which, through various mechanisms, may undergo rupture, formation of a thrombus and subsequent onset of a CV event (ischaemic cerebrovascular accident, acute myocardial infarction or ischaemia of the lower limbs).<a class="elsevierStyleCrossRef" href="#bib0210">11</a> Artery ultrasound is a non-invasive, reproducible, validated technique with high sensitivity and specificity allowing a reliable, cost-effective diagnosis of subclinical atheromatosis to be made. Indeed, there is a gradual trend towards its inclusion in current clinical guidelines for the management of CV risk.<a class="elsevierStyleCrossRefs" href="#bib0215">12,13</a>One of the diseases with high CV mortality and a elevated prevalence of atheromatosis is CKD.<a class="elsevierStyleCrossRefs" href="#bib0225">14,15</a> CKD gradually increases with age (22% in those over age 64 and 40% of those over age 80), type 2 diabetes and hypertension (35–40% in diabetic or hypertensive patients).<a class="elsevierStyleCrossRef" href="#bib0235">16</a> Patients with CKD are asymptomatic until the disease is advanced and in the majority of cases, at the time of the diagnosis of CKD the patient requires referral to a specialised physician for replacement treatment either with dialysis or transplantation, with a high associated healthcare cost. In Spain, it is estimated that 10% of the adult population (20% in those over age 65) have hidden kidney disease (HKD) and that 40% will die of CV disease before entering a dialysis programme.<a class="elsevierStyleCrossRef" href="#bib0240">17</a>Therefore, due to the high morbidity and mortality of subclinical atheromatous disease (SAD) and HKD it is justified to propose an epidemiological study to determine its prevalence in the asymptomatic population with at least one CV risk factor. There are no studies addressing the impact of early diagnosis of SAD and HKD on CV morbidity and mortality, CKD progression and clinical management in primary care level (PC).In the ILERVAS study we propose performing an overall assessment of CV and renal risk with non-invasive diagnostic tools. To do this, we propose a collaborative study that involves different research groups from the Instituto de Investigación Biomédica de Lleida (IRBLleida) that will provide specific diagnostic methods from their specialty, and that will be conducted sequentially during the journey made by individuals within the mobile unit (MU) (<a class="elsevierStyleCrossRefs" href="#fig0005">Figs. 1 and 2</a>).<elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia>The general aims of the ILERVAS proposal are:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">(1)To determine the prevalence of SAD and HKD in the asymptomatic general population with at least one CV risk factor.</li><li class="elsevierStyleListItem" id="lsti0010">(2)To analyse the impact of the interventions performed in the MU on CV morbidity and mortality and CKD progression during a 10-year follow-up period.</li><li class="elsevierStyleListItem" id="lsti0015">(3)To have a platform for data encompassing baseline data (clinical, clinical-chemistry and biobank) and follow-up data allowing the association between the different known and emerging risk factors and SAD, HKD, CV morbidity and mortality, and CKD progression to be analysed. These factors include:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0020">a.Biomarkers (proteomics, metabolomics, lipidomics and genetic polymorphisms).</li><li class="elsevierStyleListItem" id="lsti0025">b.Lung capacity and sleep abnormalities.</li><li class="elsevierStyleListItem" id="lsti0030">c.Advanced glycation end products (AGEs).</li><li class="elsevierStyleListItem" id="lsti0035">d.Diet and physical activity.</li><li class="elsevierStyleListItem" id="lsti0040">e.Traditional risk factors.</li></ul></li></ul>MethodsStudy design and populationA randomised interventional study with 2 arms that will include 19,800 individuals with at least one CV risk factor, registered in PC in the province of Lleida, between January 2015 and December 2017, who will subsequently be followed up until January 2025. The ILERVAS study protocol, information about the population, location of the MU, informative videos and materials about CV disease, contact information and publications will be available on the following website: <a id="intr0010" class="elsevierStyleInterRef" href="http://www.elbusdelasalut.cat/">www.elbusdelasalut.cat/</a>.Source of information and instruments for data collectionSociodemographic variables (age, sex and race), medical history of comorbidities and medical treatments will be collected from the electronic PC medical history (e-CAP).The other variables will be collected in the MU, which will travel throughout the province of Lleida. This MU is has the equipment to perform vascular diagnostic tests, spirometry and collection of anthropometric and clinical-chemistry data. In addition, variables related to physical exercise will be collected from the International Physical Activity Questionnaire (IPAQ),<a class="elsevierStyleCrossRef" href="#bib0245">18</a> variables related to diet will be collected from the diet survey adapted from the PREDIMED study<a class="elsevierStyleCrossRef" href="#bib0250">19</a> and variables related to daytime somnolence will be collected from the Berlin questionnaire<a class="elsevierStyleCrossRef" href="#bib0255">20</a> and the Epworth somnolence scale.<a class="elsevierStyleCrossRef" href="#bib0260">21</a>Each week, all ILERVAS study data entered in the e-CAP will be extracted for quality control and to be exported to a general database designed for this purpose.Participant selectionThe participant selection process is shown in <a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>. From a total of 410,246 people with an open history in the e-CAP (on October 24, 2014), the study population that meets the inclusion criteria will be identified. The inclusion criteria are: women between the ages of 50 and 70 and men between the ages of 45 and 65 with at least one CV risk factor (hypertension, dyslipidaemia, obesity, smoking habit, first-degree family history of early CV disease), no prior medical history of CV disease, diabetes, CKD or active neoplasm, and a life expectancy no shorter than 18 months (n=46,069). Of these, a total of 19,800 people (9900 in the intervention group and 9900 in the control group) will be selected through simple randomisation without replacement, within clusters defined by basic healthcare area, PC centre or doctor's office, in accordance with the total number of people who may be visited in the MU during f one year period (20 patients per working day). Each day 10 people will be added to cover a potential non-response rate of up to 50%. Finally, 3300 people per year will be studied in the MU, following selection of a total of 4950 candidates each year. From the second year of the study, sample selection will be performed every six months. People who have participated in previous years will be excluded. To identify the population with no electronic medical history in the e-CAP (Val d’Aran, Solsonès and Cerdanya) the ILERVAS team will request information from the responsible of each healthcare area.<elsevierMultimedia ident="fig0015"></elsevierMultimedia>The participants selected will be informed of the study objectives and the diagnostic tests to be performed by means of a personalised letter with an appointment day and time. Prior to the inclussion in the study they must sign the informed consent form. The study protocol has been approved by the Hospital Universitario Arnau de Vilanova (Lleida) Ethics Committee.One month before the MU reaches each population, 2 investigators responsible for the project will travel to hold meetings on information and updates about subclinical atheromatous arterial disease, HKD and abdominal aortic aneurysm; to explain the project to healthcare workers and administrators of the different healthcare basic areas; and to help with the interpretation of the results of the examinations and recommendations that will be included in the ILERVAS final report in the electronic medical history of each patient which are based on clinical practice guidelines<a class="elsevierStyleCrossRefs" href="#bib0205">10,22–25</a> (<a class="elsevierStyleCrossRef" href="#sec0120">Appendix B: Supplementary material</a>).Follow-up periodAs this is an asymptomatic population with a low to moderate CV risk, a minimum 10-year follow-up period has been established to observe the onset of CV events.<a class="elsevierStyleCrossRefs" href="#bib0285">26,27</a> Initially the cohort will be followed up from January 2015 to January 2025. The follow-up period may be lengthened, given that all data will be recorded in the e-CAP. The population selected will be monitored every six months to collect changes in medical history related to the study objectives.Cardiovascular events and CKD progressionThe onset of a CV event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10), which includes: angina pectoris, myocardial infarction, transient ischaemic attack, cerebrovascular accident, heart failure, arrhythmia, peripheral artery disease, aortic aneurysm, revascularisation and angioplasty of any artery region. Likewise, the patient's cause of death, whether of CV origin (myocardial infarction, arrhythmia, heart failure, cerebrovascular accident, aortic aneurysm, mesenteric infarction or sudden death) or of non-CV origin (infections, cancers, accident or kidney disease) will be recorded.The information sources used to identify CV events will be: review of medical records (through the e-CAP) and consultation of the Catalonia mortality registry.CKD progression is defined as a doubling of creatinine or entry into renal replacement therapy, and will also be collected through the e-CAP.Vascular ultrasoundThe examination and reading will be performed by 2 nurses specialised in vascular imaging diagnostics, following a standardised protocol with the patient in supine decubitus.<a class="elsevierStyleCrossRef" href="#bib0295">28</a> The VIVID I version BT12 ultrasound system (GE Healthcare) will be used. The system has a 12L-RS/4–13MHz linear probe (ultrasound of the carotid and femoral arteries), a 4C-RS/1.5–6MHz convex probe (ultrasound of the abdominal aorta) and a 3S-RS/1.5–2.5MHz sector probe (transcranial ultrasound). It also has a module for measuring intima-media thickness and pulsed Doppler ultrasound to assess haemodynamic abnormalities in the case that atheromatous plaques are present, and also to analyse the intracranial circulation. The DICOM network connectivity system will be used to record the results and ultrasound images online in the e-CAP.Carotid arteriesA total of 8 vascular regions will be analysed (common carotid, bifurcation or bulb, internal carotid and external carotid), with the patient in supine decubitus and the head turned 45° towards the opposite side in the examination. The transversal examination will be started with a 2D longitudinal slice of the common carotid up to the bifurcation. At this level colour Doppler will be used to distinguish the external carotid from the internal carotid and then examine both carotids simultaneously.The presence of an atheromatous plaque will be identified as an intima-media thickness with a height greater than 1.5mm.<a class="elsevierStyleCrossRef" href="#bib0295">28</a> In the event that a plaque is demonstrated, the degree of stenosis (<50%, 50–70% or 70–99%) will be quantified by colour and pulsed Doppler and the peak systolic velocity (PSV in cm/s), peak diastolic velocity (PDVcm/s) and ratio (between common carotid and the location of the stenosis) will be determined to assess the degree of haemodynamic abnormality.Femoral arteriesWith the patient in supine decubitus, the presence of a plaque will be examined in the common femoral artery (1cm proximal to the bifurcation) and the superficial femoral artery on both sides. The same criterion will be followed for definition of an atheromatous plaque.Abdominal aortaThe aim is to measure the diameter of the abdominal aorta for early diagnosis of aortic aneurysm in men age 60 and older. With the patient in supine decubitus, the abdominal aorta will be examined in the midline of the abdomen from the base of the sternum until the bifurcation the iliac arteries is visualised. In an axial view, at the points where a greater diameter is observed, 2 images of the aorta will be captured, and 2 measurements will be made (anterior–posterior and lateral–lateral). An aortic aneurysm will be considered to be present when the diameter is greater than 3cm.Transcranial ultrasoundThe arteries of the circle of Willis and their branches will be insonated through the transtemporal and transforaminal acoustic windows. The Doppler spectrum of each intracranial artery will be determined using the colour-coded signal. Flow direction, peak systolic velocity, mean flow velocity and diastolic flow velocity will be established. The intracranial carotid artery, the medial cerebral artery in the M1 and M2 segments, the anterior cerebral artery (segment A1) and the posterior cerebral artery in segments P1 and P2 will be studied through the transtemporal acoustic window.The V4 segment of the vertebral arteries and the basilar artery will be studied through the transforaminal acoustic window. In each patient the number, location and severity of stenoses will be recorded. Baumgartner's criteria will be used to establish the severity of the stenosis based on peak systolic wave velocity (moderate to serious stenosis, if it is ≥155/≥220cm/s for the medial cerebral artery, ≤120/≥155cm/s for the anterior cerebral artery, ≥100/≥145cm/s for the posterior cerebral artery and the basilar artery, and ≥90/≥120cm/s for the vertebral artery).<a class="elsevierStyleCrossRef" href="#bib0300">29</a>Ankle–brachial indexA continuous Doppler (Hadecco ES100X MiniDop), sphygmomanometer and blood pressure cuffs (Riester minimus III) will be used. Systolic blood pressure will be measured in the brachial artery, posterior tibial artery and dorsalis pedis artery in both limbs. The ratios between tibial and pedal systolic blood pressure in each leg and the higher brachial blood pressure will be calculated. The final value for each limb will be the lower value of those obtained between tibial and pedal blood pressure.<a class="elsevierStyleCrossRef" href="#bib0305">30</a> An ankle–brachial index value <0.9 will be considered to be suggestive of stenosis; a value <0.7 will be considered to be stenosis and a value ≥1.4 will be considered to be suggestive of rigidity.SpirometrySpirometry will be used to assess lung capacity. It will be performed by the same nurse who will measure forced vital capacity (FVC); forced expiratory volume in one second (FEV1); the ratio between FEV1 and FVC and the lower limit of normality, as a percentage.Determination of advanced glycation end productsThese will be measured using skin autofluorescence (SAF) in the forearm with the AGE Reader® system (Diagnoptics, the Netherlands). SAF is measured using spectrophotometry which is calculated as the relationship of the intensity of reflected light compared to refracted light. The result obtained will be divided into 4CV risk groups, taking into account age and sex.Clinical and clinical-chemistry dataThe following variables will be recorded:<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0045">-Weight, height, waist circumference and neck circumference. Self-calculable body mass index in kg/m2.</li><li class="elsevierStyleListItem" id="lsti0050">-Systolic blood pressure, diastolic blood pressure and pulse pressure (mmHg). These will be measured 3 times (Omron 6) at 2-min intervals and the mean of the last 2 will be collected.</li><li class="elsevierStyleListItem" id="lsti0055">-Hours of fasting.</li><li class="elsevierStyleListItem" id="lsti0060">-Dried capillary blood testing (fingertip puncture): creatinine (mg/dl), uric acid (mg/dl) and total cholesterol (mg/dl), using the Reflotrons® Plus system (Roche). Determination of the complete lipid profile in cases in which total cholesterol is greater than 200mg/dl: HDL cholesterol (mg/dl), LDL cholesterol (mg/dl) and triglycerides (mg/dl) (Cobas B 101® system [Roche]). Calculation of non-HDL cholesterol levels (total cholesterol – HDL cholesterol [mg/dl]). Glycated haemoglobin (%) will be analysed with the Cobas B 101 system (Roche).</li><li class="elsevierStyleListItem" id="lsti0065">-From the creatinine value, taking into account race and sex, the CKD-EPI glomerular filtration rate will be determined.<a class="elsevierStyleCrossRef" href="#bib0310">31</a></li><li class="elsevierStyleListItem" id="lsti0070">-Urine sample laboratory testing: using Clinitek Microalbumin 2 Reagent Strips and a Siemens Clinitek Status® analyser from a urine sample from spontaneous micturition collected in the bus itself (which has a bathroom): albuminuria (mg/l) and albumin/creatinine ratio (mg/g).</li></ul>Biobank<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0075">-Drawing of blood samples from a peripheral vein of the hand or forearm to obtain serum, plasma, DNA and RNA. These samples will be prepared in aliquots following a standardised protocol, and sent frozen (dry ice) to a centralised biobank (RedinRen at Universidad de Alcalá) for processing and storage for subsequent studies of CV, inflammatory and mineral-metabolism biomarkers and genetic polymorphisms.</li><li class="elsevierStyleListItem" id="lsti0080">-Urine samples frozen and stored in a biobank for subsequent study of biomarkers.</li></ul>Statistical analysisDescriptive analysis will include absolute and relative frequencies for the qualitative variables, means and standard deviations for the continuous variables that follow a normal distribution, and median and interquartile range in the cases that do not follow a normal distribution. Their distribution will be analysed with the chi-squared test, in the case of qualitative variables, and Student's t test or ANOVA for quantitative variables with a normal distribution, or, failing this, non-parametric Mann–Whitney U or Kruskal–Wallis tests will be used for those without a normal distribution. The correlation between quantitative variables will be analysed using Pearson's or Spearman's test, depending on the distribution. Variables with outliers will be processed for their standardisation and subsequent analysis. The existence of collinearity between 2 variables will be analysed to enter the variable that better predicts the result variable in the multivariate model.Multivariate analysis will be performed using logistic regression if the dependent variable is qualitative, or linear regression if it is quantitative. Beta regression coefficients, odds ratios (ORs) and their respective 95% confidence intervals will be estimated as measures of association. In the longitudinal study, the incidence of CV morbidity and mortality and mortality due to any cause will be analysed, based on the diagnostic tests used in the MU and the biomarkers studied using Cox regression. Statistical significance will be set at a p value<0.05. The SPSS version 21 (SPSS Inc. Chicago, United States) software program will be used for data analysis.The results will be weighted by the inverse of the probability of selection which requires the selection strategy applied in the sampling phase. Results will be provided for both the entire province and each predefined territory within the province, applying the corresponding post-stratification weights in each case.An initial general data analysis in the first 3 months of each year (January–March 2016, 2017 and 2018) is planned.The first publication will make reference to the overall results of the study (prevalence of atheromatous disease and HKD). Subsequently potential differences in prevalence between regions and the effects of diet, exercise, changes in habits, changes in medication and other factors will be analysed.In a second phase, the relationship between CV events (major and minor) and CKD progression for the group that has been included in the MU compared to the group with the same inclusion criteria, but that has not been studied in the MU, will be analysed.DiscussionThe ILERVAS project is the first study that will make a diagnosis of the prevalence of SAD and HKD in an asymptomatic population with at least one CV risk factor and link both diseases with CV morbidity and mortality over time (10 years). In addition, it will determine whether early diagnosis of both diseases results in a health benefit. It will also contribute to the knowledge on the impact of respiratory diseases and biomarkers on CV risk and will show the prevalence of unknown cases of diabetes, dyslipidaemia and hyperuricaemia. One notable consideration is that this will allow inequalities in health linked to region, diet and socioeconomic level to be detected.The use of imaging diagnostic tools will allow early identification of atheromatous disease and therefore early identification of patients with a high risk of having a CV event in the future. In addition, this project has an added value in terms of primary prevention. In this regard, healthcare education that will emphasise modifiable risk factors common to all the diseases studied, such as obesity, smoking habit, sedentary lifestyle and hypertension, will be carried out in the MU and at the PC centres.Working with a shared medical history will enrich the project, allow long-term follow-up of patients and reveal the impact of early diagnosis of atheromatosis (artery ultrasound) in CV prediction, management and prevention, as well as HKD detection, on the incidence of dialysis, compared to those patients with the same risk factors who have not visited the MU and who are managed according to conventional CV risk calculation population tables. In addition, assessment of new biomarkers and genetic polymorphisms will add predictive value to the known risk factors for both diseases. Knowledge of factors may set the basis for the development of a more precise and personalised care that should help to reduce the incidence of these diseases.An added value is that this database will be fed without interruption, as it will be shared with the electronic history used daily in PC, which will allow access to clinical and clinical-chemistry parameters and CV events throughout time. All this, together with the parameters of proteomics, metabolomics, genetic polymorphisms and other biomarkers, will contribute to the creation of a large-scale database. Its analysis (computation and modelling) will involve the collaboration of experts in management of big data from the Scientific and Technical Department at IRBLleida.Moreover, it is not known what are the challenges that the future may bring us regarding potential biomarkers that could allow the design of a medicine personalised with respect to risk factors and treatments. Therefore, plasma, serum, RNA, DNA and urine samples will be collected; these will be available for external investigators, after presentation of projects that will be evaluated by a scientific committee, which will take into account both the quality of the project and the assurance of having the resources required to complete it.In conclusion, the ILERVAS project aims to achieve a paradigm shift in the diagnosis of CKD and vascular disease, through improvement in accessibility of part of the population with risk factors to cost-effective interventions that allow early prevention of the onset and progression of these diseases. This will result in a reduction in the socioeconomic and health impact (reduction in hospitalisations and social and healthcare costs); which in large part are associated to a late diagnosis.FundingProject funded by the Lleida Provincial Council in collaboration with the Fundación Renal Jaume Arnó.Conflicts of interestThe authors declare that there are no conflicts of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:11 [ 0 => array:3 [ "identificador" => "xres767390" "titulo" => "Abstract" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec768541" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres767391" "titulo" => "Resumen" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0020" "titulo" => "Antecedentes y objetivos" ] 1 => array:2 [ "identificador" => "abst0025" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0030" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec768542" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:12 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design and population" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Source of information and instruments for data collection" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Participant selection" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Follow-up period" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Cardiovascular events and CKD progression" ] 5 => array:3 [ "identificador" => "sec0040" "titulo" => "Vascular ultrasound" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0045" "titulo" => "Carotid arteries" ] 1 => array:2 [ "identificador" => "sec0050" "titulo" => "Femoral arteries" ] 2 => array:2 [ "identificador" => "sec0055" "titulo" => "Abdominal aorta" ] 3 => array:2 [ "identificador" => "sec0060" "titulo" => "Transcranial ultrasound" ] ] ] 6 => array:2 [ "identificador" => "sec0065" "titulo" => "Ankle–brachial index" ] 7 => array:2 [ "identificador" => "sec0070" "titulo" => "Spirometry" ] 8 => array:2 [ "identificador" => "sec0075" "titulo" => "Determination of advanced glycation end products" ] 9 => array:2 [ "identificador" => "sec0080" "titulo" => "Clinical and clinical-chemistry data" ] 10 => array:2 [ "identificador" => "sec0085" "titulo" => "Biobank" ] 11 => array:2 [ "identificador" => "sec0090" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0095" "titulo" => "Discussion" ] 7 => array:2 [ "identificador" => "sec0100" "titulo" => "Funding" ] 8 => array:2 [ "identificador" => "sec0105" "titulo" => "Conflicts of interest" ] 9 => array:2 [ "identificador" => "xack256629" "titulo" => "Acknowledgements" ] 10 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2015-12-16" "fechaAceptado" => "2016-02-15" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec768541" "palabras" => array:7 [ 0 => "Cardiovascular disease" 1 => "Atherosclerotic plaque" 2 => "Hidden kidney disease" 3 => "Early diagnosis" 4 => "Lung capacity" 5 => "Biomarkers" 6 => "Prevention" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec768542" "palabras" => array:7 [ 0 => "Enfermedad cardiovascular" 1 => "Placa de ateroma" 2 => "Enfermedad renal oculta" 3 => "Diagnóstico precoz" 4 => "Capacidad pulmonar" 5 => "Biomarcadores" 6 => "Prevención" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "Background and objectivesChronic kidney disease (CKD) and atherosclerosis are 2 interrelated diseases that increase the risk of cardiovascular morbidity and mortality. The objectives of the ILERVAS project are: (1) to determine the prevalence of subclinical arterial disease and hidden kidney disease; (2) to assess the impact of early diagnosis of both diseases on cardiovascular morbidity and mortality and also on the progression of CKD; (3) to have a platform of data and biological samples. MethodsRandomised intervention study. From 2015 to 2017, 19,800 people (9900 in the intervention group and 9900 in the control group) aged between 45 and 70 years without previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected from the primary health care centres across the province of Lleida. A team of experts will travel around in a mobile unit to carry out the following baseline tests on the intervention group: Artery ultrasound, (carotid, femoral, transcranial and abdominal aorta), ankle-brachial index, spirometry, determination of advanced glycation end products, dried blood spot and urine spot tests. Additionally, blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omics studies. Participants will be followed up until 2025 for identification of cardiovascular events, treatment changes and changes in lifestyle. ConclusionsThe ILERVAS project will reveal the prevalence of subclinical vascular disease and hidden kidney disease, determine whether or not their early diagnosis brings health benefits and will also allow investigation of new risk factors." "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "Antecedentes y objetivosLa enfermedad renal crónica (ERC) y la ateromatosis son 2 enfermedades interrelacionadas que aumentan el riesgo de morbimortalidad cardiovascular. Los objetivos del proyecto ILERVAS son: 1) conocer la prevalencia de enfermedad ateromatosa subclínica y de enfermedad renal oculta; 2) valorar el impacto de su diagnóstico precoz sobre la morbimortalidad cardiovascular y la progresión de la ERC; 3) disponer de una plataforma de datos y muestras biológicas. MétodosEstudio de intervención aleatorizado. Entre 2015 y 2017 se incluirá a 19.800 personas (9.900 en el grupo de intervención y 9.900 en el grupo control) entre 45 y 70 años, sin antecedentes de enfermedad cardiovascular y que presenten al menos un factor de riesgo cardiovascular, seleccionadas aleatoriamente de los centros de atención primaria (AP) de la provincia de Lérida. Un equipo técnico experto se desplazará con una unidad móvil para realizar las exploraciones basales al grupo de intervención: ecografía arterial (carótida, femoral, transcraneal y aorta abdominal), medición del índice tobillo-brazo, espirometría, detección de los productos de glicación avanzada y analítica seca de sangre y orina. Adicionalmente, se recogerán muestras de sangre y orina que serán almacenadas en el biobanco para identificar nuevos biomarcadores con biología de sistemas. Los participantes serán seguidos hasta 2025 para la identificación de eventos cardiovasculares, cambios de tratamiento y modificación de estilos de vida. ConclusionesEl proyecto ILERVAS permitirá conocer la prevalencia de enfermedad vascular y de enfermedad renal subclínicas, evaluar si su diagnóstico precoz tiene un beneficio en la salud e investigar factores de riesgo emergentes." "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0020" "titulo" => "Antecedentes y objetivos" ] 1 => array:2 [ "identificador" => "abst0025" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0030" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:2 [ 0 => array:3 [ "etiqueta" => "1" "nota" => "Jose Manuel Valdivielso and Elvira Fernández share senior authorship." "identificador" => "fn0005" ] 1 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Betriu A, Farràs C, Abajo M, Martinez-Alonso M, Arroyo D, Barbé F. Estudio de intervención aleatorizado para evaluar la prevalencia de enfermedad ateromatosa y renal ocultas y su impacto en la morbimortalidad: Proyecto ILERVAS. Nefrologia. 2016;36:389–396." ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "The following are the supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0120" ] ] ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 424 "Ancho" => 1448 "Tamanyo" => 113726 ] ] "descripcion" => array:1 [ "en" => "Exterior design of the mobile unit (bus and caravan)." ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 332 "Ancho" => 2335 "Tamanyo" => 81572 ] ] "descripcion" => array:1 [ "en" => "Diagnostic tests in the mobile unit. a The diagnostic test used to measure AGEs is skin autofluorescence. AGE: advanced glycation end product; SAF: skin autofluorescence." ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1789 "Ancho" => 2503 "Tamanyo" => 395058 ] ] "descripcion" => array:1 [ "en" => "Population selection diagram for the ILERVAS project. a Randomised by cluster (CAP) annually. CAP: primary care centre; CV: cardiovascular; CKD: chronic kidney disease; CVRF: cardiovascular risk factor; MU: mobile unit." ] ] 3 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.doc" "ficheroTamanyo" => 78848 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:31 [ 0 => array:3 [ "identificador" => "bib0160" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "European Society of Cardiology, the European Heart Network and the British Heart Foundation Health Promotion Research Group, Department of Public Health, University of Oxford. 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Original article

Estudio de intervención aleatorizado para evaluar la prevalencia de enfermedad ateromatosa y renal ocultas y su impacto en la morbimortalidad: Proyecto ILERVAS

Àngels Betriua,b, Cristina Farràsc, María Abajoa, Montserrat Martinez-Alonsod, David Arroyoe, Ferran Barbéf,g, Miquel Butih, Albert Lecubei, Manuel Porteroj, Francisco Purroyk, Gerard Torresl, José Manuel Valdivielsoa,m,1, Elvira Fernándeza,b,e,1,

Corresponding author

edfernandez.lleida.ics@gencat.cat

Corresponding author.

a Institut de Recerca Biomèdica (IRBLleida), Lérida, Spain

b Unidad de Diagnóstico y Tratamiento Enfermedades Aterotrombóticas (UDETMA), Servicio de Nefrología, Hospital Universitari Arnau de Vilanova, Lérida, Spain

c Área Básica de Salut Borges Blanques, Lérida, Spain

d Departamento Bioestadística, IRBLleida, Lérida, Spain

e Servicio de Nefrología, Hospital Universitari Arnau de Vilanova, Lérida, Spain

f Servicio de Neumología, Hospital Universitari Arnau de Vilanova, Lérida, Spain

g Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain

h Dirección de Atención Primaria, Lérida, Spain

i Servicio de Endocrinología, Hospital Universitari Arnau de Vilanova, Lérida, Spain

j Grupo de Fisiopatología Metabólica, Departamento de Medicina Experimental, IRBLleida, Lérida, Spain

k Servicio de Neurología, Hospital Universitari Arnau de Vilanova, Lérida, Spain

l Servicio de Medicina Interna, Hospital Universitari de Santa María, Lérida, Spain

m Laboratorio de Nefrología Experimental, IRBLleida, Lérida, Spain

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        "titulo" => "Estudio de intervenci&#243;n aleatorizado para evaluar la prevalencia de enfermedad ateromatosa y renal ocultas y su impacto en la morbimortalidad&#58; Proyecto ILERVAS"
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Population selection diagram for the ILERVAS project&#46; <span class="elsevierStyleSup">a</span> Randomised by cluster &#40;CAP&#41; annually&#46; CAP&#58; primary care centre&#59; CV&#58; cardiovascular&#59; CKD&#58; chronic kidney disease&#59; CVRF&#58; cardiovascular risk factor&#59; MU&#58; mobile unit&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Cardiovascular &#40;CV&#41; diseases are the leading cause of morbidity and mortality worldwide&#44; with a major social&#44; healthcare-related and economic impact&#46; In 2012&#44; in the European Union&#44; CV disease accounted for 40&#37; of overall mortality with a cost of &#8364;196<span class="elsevierStyleHsp" style=""></span>billion&#44; distributed as follows&#58; 54&#37; for healthcare spending&#44; 24&#37; for lost productivity and 22&#37; for care of patients with CV disease&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">1</span></a> In the same year&#44; in Spain&#44; CV disease accounted for 30&#37; of all recorded deaths and 15&#37; of all hospital admissions&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">2</span></a> In the Spanish province of Lleida&#44; in 2012&#44; CV disease was the leading cause of death&#44; with a prevalence of 26&#37; of ischaemic heart disease of and 27&#37;&#46;of cerebrovascular events&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Risk calculation tables &#40;Framingham&#44; Score&#44; Regicor&#41; based on traditional CV risk factors such as age&#44; sex&#44; smoking habit&#44; blood pressure&#44; total cholesterol and diabetes have been used to detect the population susceptible of having a CV event&#46; However&#44; these calculations do not take into account other factors that also have an impact&#46; These factors include&#44; but are not limited to a history of early CV disease in first-degree relatives &#40;men before age 55&#44; women before age 65&#41;&#44; genetic factors and individual susceptibility&#44; obesity&#44; socioeconomic level&#44; sleep apnoea&#44; and chronic kidney disease &#40;CKD&#41;&#46; It has been indicated that more than 60&#37; of CV events occur in individuals with a low to moderate calculated risk&#44; and that 4 of every 10 cases of miocardial infarction or sudden death occur in people with no prior history of CV disease&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Numerous population studies&#44; based on large cohorts and long periods of follow-up&#44; have demonstrated a clear association between the presence of an atheromatous plaque in the carotid arteries and the risk of having a coronary or cerebrovascular event &#40;1&#46;8&#8211;4&#46;1&#44; respectively&#41;&#44; and have concluded that a diagnosis of subclinical atheromatosis increases the predictive value of traditional risk equations&#44; which reclassify individuals according to degrees of risk greater than those calculated by these algorithms&#46;<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">5&#8211;9</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Atheromatous disease is characterised by a chronic&#44; proliferative and multifactorial inflammatory process that affects the vascular bed such that atheromatous plaques form in medium- to large-sized arteries walls &#40;carotid&#44; femoral&#44; cerebral&#44; coronary and renal&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">10</span></a> The clinical manifestations will depend on both the area and the number of vascular regions affected&#44; and on the volume and vulnerability of the atheromatous plaque which&#44; through various mechanisms&#44; may undergo rupture&#44; formation of a thrombus and subsequent onset of a CV event &#40;ischaemic cerebrovascular accident&#44; acute myocardial infarction or ischaemia of the lower limbs&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">11</span></a> Artery ultrasound is a non-invasive&#44; reproducible&#44; validated technique with high sensitivity and specificity allowing a reliable&#44; cost-effective diagnosis of subclinical atheromatosis to be made&#46; Indeed&#44; there is a gradual trend towards its inclusion in current clinical guidelines for the management of CV risk&#46;<a class="elsevierStyleCrossRefs" href="#bib0215"><span class="elsevierStyleSup">12&#44;13</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">One of the diseases with high CV mortality and a elevated prevalence of atheromatosis is CKD&#46;<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">14&#44;15</span></a> CKD gradually increases with age &#40;22&#37; in those over age 64 and 40&#37; of those over age 80&#41;&#44; type 2 diabetes and hypertension &#40;35&#8211;40&#37; in diabetic or hypertensive patients&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0235"><span class="elsevierStyleSup">16</span></a> Patients with CKD are asymptomatic until the disease is advanced and in the majority of cases&#44; at the time of the diagnosis of CKD the patient requires referral to a specialised physician for replacement treatment either with dialysis or transplantation&#44; with a high associated healthcare cost&#46; In Spain&#44; it is estimated that 10&#37; of the adult population &#40;20&#37; in those over age 65&#41; have hidden kidney disease &#40;HKD&#41; and that 40&#37; will die of CV disease before entering a dialysis programme&#46;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">17</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Therefore&#44; due to the high morbidity and mortality of subclinical atheromatous disease &#40;SAD&#41; and HKD it is justified to propose an epidemiological study to determine its prevalence in the asymptomatic population with at least one CV risk factor&#46; There are no studies addressing the impact of early diagnosis of SAD and HKD on CV morbidity and mortality&#44; CKD progression and clinical management in primary care level &#40;PC&#41;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In the ILERVAS study we propose performing an overall assessment of CV and renal risk with non-invasive diagnostic tools&#46; To do this&#44; we propose a collaborative study that involves different research groups from the Instituto de Investigaci&#243;n Biom&#233;dica de Lleida &#40;IRBLleida&#41; that will provide specific diagnostic methods from their specialty&#44; and that will be conducted sequentially during the journey made by individuals within the mobile unit &#40;MU&#41; &#40;<a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1 and 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">The general aims of the ILERVAS proposal are&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#40;1&#41;</span><p id="par0045" class="elsevierStylePara elsevierViewall">To determine the prevalence of SAD and HKD in the asymptomatic general population with at least one CV risk factor&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#40;2&#41;</span><p id="par0050" class="elsevierStylePara elsevierViewall">To analyse the impact of the interventions performed in the MU on CV morbidity and mortality and CKD progression during a 10-year follow-up period&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#40;3&#41;</span><p id="par0055" class="elsevierStylePara elsevierViewall">To have a platform for data encompassing baseline data &#40;clinical&#44; clinical-chemistry and biobank&#41; and follow-up data allowing the association between the different known and emerging risk factors and SAD&#44; HKD&#44; CV morbidity and mortality&#44; and CKD progression to be analysed&#46; These factors include&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">a&#46;</span><p id="par0060" class="elsevierStylePara elsevierViewall">Biomarkers &#40;proteomics&#44; metabolomics&#44; lipidomics and genetic polymorphisms&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">b&#46;</span><p id="par0065" class="elsevierStylePara elsevierViewall">Lung capacity and sleep abnormalities&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">c&#46;</span><p id="par0070" class="elsevierStylePara elsevierViewall">Advanced glycation end products &#40;AGEs&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">d&#46;</span><p id="par0075" class="elsevierStylePara elsevierViewall">Diet and physical activity&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">e&#46;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Traditional risk factors&#46;</p></li></ul></p></li></ul></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Study design and population</span><p id="par0085" class="elsevierStylePara elsevierViewall">A randomised interventional study with 2 arms that will include 19&#44;800 individuals with at least one CV risk factor&#44; registered in PC in the province of Lleida&#44; between January 2015 and December 2017&#44; who will subsequently be followed up until January 2025&#46; The ILERVAS study protocol&#44; information about the population&#44; location of the MU&#44; informative videos and materials about CV disease&#44; contact information and publications will be available on the following website&#58; <a id="intr0010" class="elsevierStyleInterRef" href="http://www.elbusdelasalut.cat/">www&#46;elbusdelasalut&#46;cat&#47;</a>&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Source of information and instruments for data collection</span><p id="par0090" class="elsevierStylePara elsevierViewall">Sociodemographic variables &#40;age&#44; sex and race&#41;&#44; medical history of comorbidities and medical treatments will be collected from the electronic PC medical history &#40;e-CAP&#41;&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The other variables will be collected in the MU&#44; which will travel throughout the province of Lleida&#46; This MU is has the equipment to perform vascular diagnostic tests&#44; spirometry and collection of anthropometric and clinical-chemistry data&#46; In addition&#44; variables related to physical exercise will be collected from the International Physical Activity Questionnaire &#40;IPAQ&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">18</span></a> variables related to diet will be collected from the diet survey adapted from the PREDIMED study<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">19</span></a> and variables related to daytime somnolence will be collected from the Berlin questionnaire<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">20</span></a> and the Epworth somnolence scale&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">21</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall">Each week&#44; all ILERVAS study data entered in the e-CAP will be extracted for quality control and to be exported to a general database designed for this purpose&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Participant selection</span><p id="par0105" class="elsevierStylePara elsevierViewall">The participant selection process is shown in <a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#46; From a total of 410&#44;246 people with an open history in the e-CAP &#40;on October 24&#44; 2014&#41;&#44; the study population that meets the inclusion criteria will be identified&#46; The inclusion criteria are&#58; women between the ages of 50 and 70 and men between the ages of 45 and 65 with at least one CV risk factor &#40;hypertension&#44; dyslipidaemia&#44; obesity&#44; smoking habit&#44; first-degree family history of early CV disease&#41;&#44; no prior medical history of CV disease&#44; diabetes&#44; CKD or active neoplasm&#44; and a life expectancy no shorter than 18 months &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>46&#44;069&#41;&#46; Of these&#44; a total of 19&#44;800 people &#40;9900 in the intervention group and 9900 in the control group&#41; will be selected through simple randomisation without replacement&#44; within clusters defined by basic healthcare area&#44; PC centre or doctor&#39;s office&#44; in accordance with the total number of people who may be visited in the MU during f one year period &#40;20 patients per working day&#41;&#46; Each day 10 people will be added to cover a potential non-response rate of up to 50&#37;&#46; Finally&#44; 3300 people per year will be studied in the MU&#44; following selection of a total of 4950 candidates each year&#46; From the second year of the study&#44; sample selection will be performed every six months&#46; People who have participated in previous years will be excluded&#46; To identify the population with no electronic medical history in the e-CAP &#40;Val d&#8217;Aran&#44; Solson&#232;s and Cerdanya&#41; the ILERVAS team will request information from the responsible of each healthcare area&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">The participants selected will be informed of the study objectives and the diagnostic tests to be performed by means of a personalised letter with an appointment day and time&#46; Prior to the inclussion in the study they must sign the informed consent form&#46; The study protocol has been approved by the Hospital Universitario Arnau de Vilanova &#40;Lleida&#41; Ethics Committee&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">One month before the MU reaches each population&#44; 2 investigators responsible for the project will travel to hold meetings on information and updates about subclinical atheromatous arterial disease&#44; HKD and abdominal aortic aneurysm&#59; to explain the project to healthcare workers and administrators of the different healthcare basic areas&#59; and to help with the interpretation of the results of the examinations and recommendations that will be included in the ILERVAS final report in the electronic medical history of each patient which are based on clinical practice guidelines<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">10&#44;22&#8211;25</span></a> &#40;<a class="elsevierStyleCrossRef" href="#sec0120">Appendix B&#58; Supplementary material</a>&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Follow-up period</span><p id="par0120" class="elsevierStylePara elsevierViewall">As this is an asymptomatic population with a low to moderate CV risk&#44; a minimum 10-year follow-up period has been established to observe the onset of CV events&#46;<a class="elsevierStyleCrossRefs" href="#bib0285"><span class="elsevierStyleSup">26&#44;27</span></a> Initially the cohort will be followed up from January 2015 to January 2025&#46; The follow-up period may be lengthened&#44; given that all data will be recorded in the e-CAP&#46; The population selected will be monitored every six months to collect changes in medical history related to the study objectives&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Cardiovascular events and CKD progression</span><p id="par0125" class="elsevierStylePara elsevierViewall">The onset of a CV event will be recorded according to the tenth version of the International Statistical Classification of Diseases &#40;ICD-10&#41;&#44; which includes&#58; angina pectoris&#44; myocardial infarction&#44; transient ischaemic attack&#44; cerebrovascular accident&#44; heart failure&#44; arrhythmia&#44; peripheral artery disease&#44; aortic aneurysm&#44; revascularisation and angioplasty of any artery region&#46; Likewise&#44; the patient&#39;s cause of death&#44; whether of CV origin &#40;myocardial infarction&#44; arrhythmia&#44; heart failure&#44; cerebrovascular accident&#44; aortic aneurysm&#44; mesenteric infarction or sudden death&#41; or of non-CV origin &#40;infections&#44; cancers&#44; accident or kidney disease&#41; will be recorded&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">The information sources used to identify CV events will be&#58; review of medical records &#40;through the e-CAP&#41; and consultation of the Catalonia mortality registry&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">CKD progression is defined as a doubling of creatinine or entry into renal replacement therapy&#44; and will also be collected through the e-CAP&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Vascular ultrasound</span><p id="par0140" class="elsevierStylePara elsevierViewall">The examination and reading will be performed by 2 nurses specialised in vascular imaging diagnostics&#44; following a standardised protocol with the patient in supine decubitus&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">28</span></a> The VIVID I version BT12 ultrasound system &#40;GE Healthcare&#41; will be used&#46; The system has a 12L-RS&#47;4&#8211;13<span class="elsevierStyleHsp" style=""></span>MHz linear probe &#40;ultrasound of the carotid and femoral arteries&#41;&#44; a 4C-RS&#47;1&#46;5&#8211;6<span class="elsevierStyleHsp" style=""></span>MHz convex probe &#40;ultrasound of the abdominal aorta&#41; and a 3S-RS&#47;1&#46;5&#8211;2&#46;5<span class="elsevierStyleHsp" style=""></span>MHz sector probe &#40;transcranial ultrasound&#41;&#46; It also has a module for measuring intima-media thickness and pulsed Doppler ultrasound to assess haemodynamic abnormalities in the case that atheromatous plaques are present&#44; and also to analyse the intracranial circulation&#46; The DICOM network connectivity system will be used to record the results and ultrasound images online in the e-CAP&#46;</p><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Carotid arteries</span><p id="par0145" class="elsevierStylePara elsevierViewall">A total of 8 vascular regions will be analysed &#40;common carotid&#44; bifurcation or bulb&#44; internal carotid and external carotid&#41;&#44; with the patient in supine decubitus and the head turned 45&#176; towards the opposite side in the examination&#46; The transversal examination will be started with a 2D longitudinal slice of the common carotid up to the bifurcation&#46; At this level colour Doppler will be used to distinguish the external carotid from the internal carotid and then examine both carotids simultaneously&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">The presence of an atheromatous plaque will be identified as an intima-media thickness with a height greater than 1&#46;5<span class="elsevierStyleHsp" style=""></span>mm&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">28</span></a> In the event that a plaque is demonstrated&#44; the degree of stenosis &#40;&#60;50&#37;&#44; 50&#8211;70&#37; or 70&#8211;99&#37;&#41; will be quantified by colour and pulsed Doppler and the peak systolic velocity &#40;PSV in cm&#47;s&#41;&#44; peak diastolic velocity &#40;PDV<span class="elsevierStyleHsp" style=""></span>cm&#47;s&#41; and ratio &#40;between common carotid and the location of the stenosis&#41; will be determined to assess the degree of haemodynamic abnormality&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Femoral arteries</span><p id="par0155" class="elsevierStylePara elsevierViewall">With the patient in supine decubitus&#44; the presence of a plaque will be examined in the common femoral artery &#40;1<span class="elsevierStyleHsp" style=""></span>cm proximal to the bifurcation&#41; and the superficial femoral artery on both sides&#46; The same criterion will be followed for definition of an atheromatous plaque&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Abdominal aorta</span><p id="par0160" class="elsevierStylePara elsevierViewall">The aim is to measure the diameter of the abdominal aorta for early diagnosis of aortic aneurysm in men age 60 and older&#46; With the patient in supine decubitus&#44; the abdominal aorta will be examined in the midline of the abdomen from the base of the sternum until the bifurcation the iliac arteries is visualised&#46; In an axial view&#44; at the points where a greater diameter is observed&#44; 2 images of the aorta will be captured&#44; and 2 measurements will be made &#40;anterior&#8211;posterior and lateral&#8211;lateral&#41;&#46; An aortic aneurysm will be considered to be present when the diameter is greater than 3<span class="elsevierStyleHsp" style=""></span>cm&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Transcranial ultrasound</span><p id="par0165" class="elsevierStylePara elsevierViewall">The arteries of the circle of Willis and their branches will be insonated through the transtemporal and transforaminal acoustic windows&#46; The Doppler spectrum of each intracranial artery will be determined using the colour-coded signal&#46; Flow direction&#44; peak systolic velocity&#44; mean flow velocity and diastolic flow velocity will be established&#46; The intracranial carotid artery&#44; the medial cerebral artery in the M1 and M2 segments&#44; the anterior cerebral artery &#40;segment A1&#41; and the posterior cerebral artery in segments P1 and P2 will be studied through the transtemporal acoustic window&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">The V4 segment of the vertebral arteries and the basilar artery will be studied through the transforaminal acoustic window&#46; In each patient the number&#44; location and severity of stenoses will be recorded&#46; Baumgartner&#39;s criteria will be used to establish the severity of the stenosis based on peak systolic wave velocity &#40;moderate to serious stenosis&#44; if it is &#8805;155&#47;&#8805;220<span class="elsevierStyleHsp" style=""></span>cm&#47;s for the medial cerebral artery&#44; &#8804;120&#47;&#8805;155<span class="elsevierStyleHsp" style=""></span>cm&#47;s for the anterior cerebral artery&#44; &#8805;100&#47;&#8805;145<span class="elsevierStyleHsp" style=""></span>cm&#47;s for the posterior cerebral artery and the basilar artery&#44; and &#8805;90&#47;&#8805;120<span class="elsevierStyleHsp" style=""></span>cm&#47;s for the vertebral artery&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">29</span></a></p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Ankle&#8211;brachial index</span><p id="par0175" class="elsevierStylePara elsevierViewall">A continuous Doppler &#40;Hadecco ES100X MiniDop&#41;&#44; sphygmomanometer and blood pressure cuffs &#40;Riester minimus III&#41; will be used&#46; Systolic blood pressure will be measured in the brachial artery&#44; posterior tibial artery and dorsalis pedis artery in both limbs&#46; The ratios between tibial and pedal systolic blood pressure in each leg and the higher brachial blood pressure will be calculated&#46; The final value for each limb will be the lower value of those obtained between tibial and pedal blood pressure&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">30</span></a> An ankle&#8211;brachial index value &#60;0&#46;9 will be considered to be suggestive of stenosis&#59; a value &#60;0&#46;7 will be considered to be stenosis and a value &#8805;1&#46;4 will be considered to be suggestive of rigidity&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Spirometry</span><p id="par0180" class="elsevierStylePara elsevierViewall">Spirometry will be used to assess lung capacity&#46; It will be performed by the same nurse who will measure forced vital capacity &#40;FVC&#41;&#59; forced expiratory volume in one second &#40;FEV1&#41;&#59; the ratio between FEV1 and FVC and the lower limit of normality&#44; as a percentage&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Determination of advanced glycation end products</span><p id="par0185" class="elsevierStylePara elsevierViewall">These will be measured using skin autofluorescence &#40;SAF&#41; in the forearm with the AGE Reader<span class="elsevierStyleSup">&#174;</span> system &#40;Diagnoptics&#44; the Netherlands&#41;&#46; SAF is measured using spectrophotometry which is calculated as the relationship of the intensity of reflected light compared to refracted light&#46; The result obtained will be divided into 4<span class="elsevierStyleHsp" style=""></span>CV risk groups&#44; taking into account age and sex&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Clinical and clinical-chemistry data</span><p id="par0190" class="elsevierStylePara elsevierViewall">The following variables will be recorded&#58;<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">-</span><p id="par0195" class="elsevierStylePara elsevierViewall">Weight&#44; height&#44; waist circumference and neck circumference&#46; Self-calculable body mass index in kg&#47;m<span class="elsevierStyleSup">2</span>&#46;</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">-</span><p id="par0200" class="elsevierStylePara elsevierViewall">Systolic blood pressure&#44; diastolic blood pressure and pulse pressure &#40;mmHg&#41;&#46; These will be measured 3 times &#40;Omron 6&#41; at 2-min intervals and the mean of the last 2 will be collected&#46;</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">-</span><p id="par0205" class="elsevierStylePara elsevierViewall">Hours of fasting&#46;</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">-</span><p id="par0210" class="elsevierStylePara elsevierViewall">Dried capillary blood testing &#40;fingertip puncture&#41;&#58; creatinine &#40;mg&#47;dl&#41;&#44; uric acid &#40;mg&#47;dl&#41; and total cholesterol &#40;mg&#47;dl&#41;&#44; using the Reflotrons<span class="elsevierStyleSup">&#174;</span> Plus system &#40;Roche&#41;&#46; Determination of the complete lipid profile in cases in which total cholesterol is greater than 200<span class="elsevierStyleHsp" style=""></span>mg&#47;dl&#58; HDL cholesterol &#40;mg&#47;dl&#41;&#44; LDL cholesterol &#40;mg&#47;dl&#41; and triglycerides &#40;mg&#47;dl&#41; &#40;Cobas B 101<span class="elsevierStyleSup">&#174;</span> system &#91;Roche&#93;&#41;&#46; Calculation of non-HDL cholesterol levels &#40;total cholesterol &#8211; HDL cholesterol &#91;mg&#47;dl&#93;&#41;&#46; Glycated haemoglobin &#40;&#37;&#41; will be analysed with the Cobas B 101 system &#40;Roche&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">-</span><p id="par0215" class="elsevierStylePara elsevierViewall">From the creatinine value&#44; taking into account race and sex&#44; the CKD-EPI glomerular filtration rate will be determined&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">31</span></a></p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">-</span><p id="par0220" class="elsevierStylePara elsevierViewall">Urine sample laboratory testing&#58; using Clinitek Microalbumin 2 Reagent Strips and a Siemens Clinitek Status<span class="elsevierStyleSup">&#174;</span> analyser from a urine sample from spontaneous micturition collected in the bus itself &#40;which has a bathroom&#41;&#58; albuminuria &#40;mg&#47;l&#41; and albumin&#47;creatinine ratio &#40;mg&#47;g&#41;&#46;</p></li></ul></p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Biobank</span><p id="par0225" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">-</span><p id="par0230" class="elsevierStylePara elsevierViewall">Drawing of blood samples from a peripheral vein of the hand or forearm to obtain serum&#44; plasma&#44; DNA and RNA&#46; These samples will be prepared in aliquots following a standardised protocol&#44; and sent frozen &#40;dry ice&#41; to a centralised biobank &#40;RedinRen at Universidad de Alcal&#225;&#41; for processing and storage for subsequent studies of CV&#44; inflammatory and mineral-metabolism biomarkers and genetic polymorphisms&#46;</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">-</span><p id="par0235" class="elsevierStylePara elsevierViewall">Urine samples frozen and stored in a biobank for subsequent study of biomarkers&#46;</p></li></ul></p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Statistical analysis</span><p id="par0240" class="elsevierStylePara elsevierViewall">Descriptive analysis will include absolute and relative frequencies for the qualitative variables&#44; means and standard deviations for the continuous variables that follow a normal distribution&#44; and median and interquartile range in the cases that do not follow a normal distribution&#46; Their distribution will be analysed with the chi-squared test&#44; in the case of qualitative variables&#44; and Student&#39;s <span class="elsevierStyleItalic">t</span> test or ANOVA for quantitative variables with a normal distribution&#44; or&#44; failing this&#44; non-parametric Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> or Kruskal&#8211;Wallis tests will be used for those without a normal distribution&#46; The correlation between quantitative variables will be analysed using Pearson&#39;s or Spearman&#39;s test&#44; depending on the distribution&#46; Variables with outliers will be processed for their standardisation and subsequent analysis&#46; The existence of collinearity between 2 variables will be analysed to enter the variable that better predicts the result variable in the multivariate model&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Multivariate analysis will be performed using logistic regression if the dependent variable is qualitative&#44; or linear regression if it is quantitative&#46; Beta regression coefficients&#44; odds ratios &#40;ORs&#41; and their respective 95&#37; confidence intervals will be estimated as measures of association&#46; In the longitudinal study&#44; the incidence of CV morbidity and mortality and mortality due to any cause will be analysed&#44; based on the diagnostic tests used in the MU and the biomarkers studied using Cox regression&#46; Statistical significance will be set at a <span class="elsevierStyleItalic">p</span> value<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#46; The SPSS version 21 &#40;SPSS Inc&#46; Chicago&#44; United&#160;States&#41; software program will be used for data analysis&#46;</p><p id="par0250" class="elsevierStylePara elsevierViewall">The results will be weighted by the inverse of the probability of selection which requires the selection strategy applied in the sampling phase&#46; Results will be provided for both the entire province and each predefined territory within the province&#44; applying the corresponding post-stratification weights in each case&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">An initial general data analysis in the first 3 months of each year &#40;January&#8211;March 2016&#44; 2017 and 2018&#41; is planned&#46;</p><p id="par0260" class="elsevierStylePara elsevierViewall">The first publication will make reference to the overall results of the study &#40;prevalence of atheromatous disease and HKD&#41;&#46; Subsequently potential differences in prevalence between regions and the effects of diet&#44; exercise&#44; changes in habits&#44; changes in medication and other factors will be analysed&#46;</p><p id="par0265" class="elsevierStylePara elsevierViewall">In a second phase&#44; the relationship between CV events &#40;major and minor&#41; and CKD progression for the group that has been included in the MU compared to the group with the same inclusion criteria&#44; but that has not been studied in the MU&#44; will be analysed&#46;</p></span></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Discussion</span><p id="par0270" class="elsevierStylePara elsevierViewall">The ILERVAS project is the first study that will make a diagnosis of the prevalence of SAD and HKD in an asymptomatic population with at least one CV risk factor and link both diseases with CV morbidity and mortality over time &#40;10 years&#41;&#46; In addition&#44; it will determine whether early diagnosis of both diseases results in a health benefit&#46; It will also contribute to the knowledge on the impact of respiratory diseases and biomarkers on CV risk and will show the prevalence of unknown cases of diabetes&#44; dyslipidaemia and hyperuricaemia&#46; One notable consideration is that this will allow inequalities in health linked to region&#44; diet and socioeconomic level to be detected&#46;</p><p id="par0275" class="elsevierStylePara elsevierViewall">The use of imaging diagnostic tools will allow early identification of atheromatous disease and therefore early identification of patients with a high risk of having a CV event in the future&#46; In addition&#44; this project has an added value in terms of primary prevention&#46; In this regard&#44; healthcare education that will emphasise modifiable risk factors common to all the diseases studied&#44; such as obesity&#44; smoking habit&#44; sedentary lifestyle and hypertension&#44; will be carried out in the MU and at the PC centres&#46;</p><p id="par0280" class="elsevierStylePara elsevierViewall">Working with a shared medical history will enrich the project&#44; allow long-term follow-up of patients and reveal the impact of early diagnosis of atheromatosis &#40;artery ultrasound&#41; in CV prediction&#44; management and prevention&#44; as well as HKD detection&#44; on the incidence of dialysis&#44; compared to those patients with the same risk factors who have not visited the MU and who are managed according to conventional CV risk calculation population tables&#46; In addition&#44; assessment of new biomarkers and genetic polymorphisms will add predictive value to the known risk factors for both diseases&#46; Knowledge of factors may set the basis for the development of a more precise and personalised care that should help to reduce the incidence of these diseases&#46;</p><p id="par0285" class="elsevierStylePara elsevierViewall">An added value is that this database will be fed without interruption&#44; as it will be shared with the electronic history used daily in PC&#44; which will allow access to clinical and clinical-chemistry parameters and CV events throughout time&#46; All this&#44; together with the parameters of proteomics&#44; metabolomics&#44; genetic polymorphisms and other biomarkers&#44; will contribute to the creation of a large-scale database&#46; Its analysis &#40;computation and modelling&#41; will involve the collaboration of experts in management of big data from the Scientific and Technical Department at IRBLleida&#46;</p><p id="par0290" class="elsevierStylePara elsevierViewall">Moreover&#44; it is not known what are the challenges that the future may bring us regarding potential biomarkers that could allow the design of a medicine personalised with respect to risk factors and treatments&#46; Therefore&#44; plasma&#44; serum&#44; RNA&#44; DNA and urine samples will be collected&#59; these will be available for external investigators&#44; after presentation of projects that will be evaluated by a scientific committee&#44; which will take into account both the quality of the project and the assurance of having the resources required to complete it&#46;</p><p id="par0295" class="elsevierStylePara elsevierViewall">In conclusion&#44; the ILERVAS project aims to achieve a paradigm shift in the diagnosis of CKD and vascular disease&#44; through improvement in accessibility of part of the population with risk factors to cost-effective interventions that allow early prevention of the onset and progression of these diseases&#46; This will result in a reduction in the socioeconomic and health impact &#40;reduction in hospitalisations and social and healthcare costs&#41;&#59; which in large part are associated to a late diagnosis&#46;</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Funding</span><p id="par0300" class="elsevierStylePara elsevierViewall">Project funded by the <span class="elsevierStyleGrantSponsor" id="gs1">Lleida Provincial Council</span> in collaboration with the <span class="elsevierStyleGrantSponsor" id="gs2">Fundaci&#243;n Renal Jaume Arn&#243;</span>&#46;</p></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Conflicts of interest</span><p id="par0305" class="elsevierStylePara elsevierViewall">The authors declare that there are no conflicts of interest&#46;</p></span></span>"
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            0 => "Enfermedad cardiovascular"
            1 => "Placa de ateroma"
            2 => "Enfermedad renal oculta"
            3 => "Diagn&#243;stico precoz"
            4 => "Capacidad pulmonar"
            5 => "Biomarcadores"
            6 => "Prevenci&#243;n"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Chronic kidney disease &#40;CKD&#41; and atherosclerosis are 2 interrelated diseases that increase the risk of cardiovascular morbidity and mortality&#46; The objectives of the ILERVAS project are&#58; &#40;1&#41; to determine the prevalence of subclinical arterial disease and hidden kidney disease&#59; &#40;2&#41; to assess the impact of early diagnosis of both diseases on cardiovascular morbidity and mortality and also on the progression of CKD&#59; &#40;3&#41; to have a platform of data and biological samples&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Randomised intervention study&#46; From 2015 to 2017&#44; 19&#44;800 people &#40;9900 in the intervention group and 9900 in the control group&#41; aged between 45 and 70 years without previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected from the primary health care centres across the province of Lleida&#46; A team of experts will travel around in a mobile unit to carry out the following baseline tests on the intervention group&#58; Artery ultrasound&#44; &#40;carotid&#44; femoral&#44; transcranial and abdominal aorta&#41;&#44; ankle-brachial index&#44; spirometry&#44; determination of advanced glycation end products&#44; dried blood spot and urine spot tests&#46; Additionally&#44; blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omics studies&#46; Participants will be followed up until 2025 for identification of cardiovascular events&#44; treatment changes and changes in lifestyle&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Conclusions</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The ILERVAS project will reveal the prevalence of subclinical vascular disease and hidden kidney disease&#44; determine whether or not their early diagnosis brings health benefits and will also allow investigation of new risk factors&#46;</p></span>"
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            "identificador" => "abst0005"
            "titulo" => "Background and objectives"
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        "titulo" => "Resumen"
        "resumen" => "<span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Antecedentes y objetivos</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La enfermedad renal cr&#243;nica &#40;ERC&#41; y la ateromatosis son 2 enfermedades interrelacionadas que aumentan el riesgo de morbimortalidad cardiovascular&#46; Los objetivos del proyecto ILERVAS son&#58; 1&#41; conocer la prevalencia de enfermedad ateromatosa subcl&#237;nica y de enfermedad renal oculta&#59; 2&#41; valorar el impacto de su diagn&#243;stico precoz sobre la morbimortalidad cardiovascular y la progresi&#243;n de la ERC&#59; 3&#41; disponer de una plataforma de datos y muestras biol&#243;gicas&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">M&#233;todos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Estudio de intervenci&#243;n aleatorizado&#46; Entre 2015 y 2017 se incluir&#225; a 19&#46;800 personas &#40;9&#46;900 en el grupo de intervenci&#243;n y 9&#46;900 en el grupo control&#41; entre 45 y 70 a&#241;os&#44; sin antecedentes de enfermedad cardiovascular y que presenten al menos un factor de riesgo cardiovascular&#44; seleccionadas aleatoriamente de los centros de atenci&#243;n primaria &#40;AP&#41; de la provincia de L&#233;rida&#46; Un equipo t&#233;cnico experto se desplazar&#225; con una unidad m&#243;vil para realizar las exploraciones basales al grupo de intervenci&#243;n&#58; ecograf&#237;a arterial &#40;car&#243;tida&#44; femoral&#44; transcraneal y aorta abdominal&#41;&#44; medici&#243;n del &#237;ndice tobillo-brazo&#44; espirometr&#237;a&#44; detecci&#243;n de los productos de glicaci&#243;n avanzada y anal&#237;tica seca de sangre y orina&#46; Adicionalmente&#44; se recoger&#225;n muestras de sangre y orina que ser&#225;n almacenadas en el biobanco para identificar nuevos biomarcadores con biolog&#237;a de sistemas&#46; Los participantes ser&#225;n seguidos hasta 2025 para la identificaci&#243;n de eventos cardiovasculares&#44; cambios de tratamiento y modificaci&#243;n de estilos de vida&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Conclusiones</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">El proyecto ILERVAS permitir&#225; conocer la prevalencia de enfermedad vascular y de enfermedad renal subcl&#237;nicas&#44; evaluar si su diagn&#243;stico precoz tiene un beneficio en la salud e investigar factores de riesgo emergentes&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Betriu A&#44; Farr&#224;s C&#44; Abajo M&#44; Martinez-Alonso M&#44; Arroyo D&#44; Barb&#233; F&#46; Estudio de intervenci&#243;n aleatorizado para evaluar la prevalencia de enfermedad ateromatosa y renal ocultas y su impacto en la morbimortalidad&#58; Proyecto ILERVAS&#46; Nefrologia&#46; 2016&#59;36&#58;389&#8211;396&#46;</p>"
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            "titulo" => "Supplementary data"
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          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Diagnostic tests in the mobile unit&#46; <span class="elsevierStyleSup">a</span> The diagnostic test used to measure AGEs is skin autofluorescence&#46; AGE&#58; advanced glycation end product&#59; SAF&#58; skin autofluorescence&#46;</p>"
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Population selection diagram for the ILERVAS project&#46; <span class="elsevierStyleSup">a</span> Randomised by cluster &#40;CAP&#41; annually&#46; CAP&#58; primary care centre&#59; CV&#58; cardiovascular&#59; CKD&#58; chronic kidney disease&#59; CVRF&#58; cardiovascular risk factor&#59; MU&#58; mobile unit&#46;</p>"
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        "texto" => "<p id="par0315" class="elsevierStylePara elsevierViewall">We are grateful to the entire UDETMA diagnostic imaging team&#59; the Primary Care management&#44; physicians and nurses&#59; the Regional Health Management of the province of Lleida&#59; and RedInRed&#44; Roche Diagnostics and Amgen SA for their collaboration in the project&#46;</p>"
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Article information

ISSN: 20132514
Original language: English

DOI:10.1016/j.nefroe.2016.07.006

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Year/Month	Html	Pdf	Total

2024 November	7	6	13
2024 October	48	49	97
2024 September	38	33	71
2024 August	55	65	120
2024 July	40	30	70
2024 June	54	28	82
2024 May	62	29	91
2024 April	57	38	95
2024 March	52	19	71
2024 February	53	35	88
2024 January	34	23	57
2023 December	33	19	52
2023 November	28	30	58
2023 October	34	24	58
2023 September	36	31	67
2023 August	28	24	52
2023 July	37	21	58
2023 June	49	18	67
2023 May	36	32	68
2023 April	27	18	45
2023 March	61	21	82
2023 February	33	23	56
2023 January	33	16	49
2022 December	68	36	104
2022 November	56	23	79
2022 October	62	38	100
2022 September	87	37	124
2022 August	48	44	92
2022 July	41	41	82
2022 June	32	37	69
2022 May	42	41	83
2022 April	48	53	101
2022 March	39	47	86
2022 February	44	27	71
2022 January	35	35	70
2021 December	33	43	76
2021 November	49	36	85
2021 October	57	45	102
2021 September	48	29	77
2021 August	54	50	104
2021 July	34	35	69
2021 June	36	33	69
2021 May	60	49	109
2021 April	84	61	145
2021 March	67	39	106
2021 February	76	40	116
2021 January	48	27	75
2020 December	53	28	81
2020 November	34	16	50
2020 October	46	17	63
2020 September	34	12	46
2020 August	40	19	59
2020 July	46	12	58
2020 June	41	18	59
2020 May	40	21	61
2020 April	42	17	59
2020 March	44	21	65
2020 February	50	14	64
2020 January	42	25	67
2019 December	63	32	95
2019 November	66	25	91
2019 October	55	11	66
2019 September	110	13	123
2019 August	58	20	78
2019 July	53	20	73
2019 June	97	29	126
2019 May	38	22	60
2019 April	76	33	109
2019 March	33	27	60
2019 February	25	25	50
2019 January	32	27	59
2018 December	141	45	186
2018 November	267	13	280
2018 October	204	18	222
2018 September	83	8	91
2018 August	49	21	70
2018 July	53	12	65
2018 June	63	16	79
2018 May	118	13	131
2018 April	103	9	112
2018 March	179	8	187
2018 February	49	10	59
2018 January	47	1	48
2017 December	56	12	68
2017 November	49	13	62
2017 October	34	4	38
2017 September	44	22	66
2017 August	31	26	57
2017 July	35	19	54
2017 June	37	26	63
2017 May	33	19	52
2017 April	44	17	61
2017 March	41	14	55
2017 February	26	28	54
2017 January	20	11	31
2016 December	41	12	53
2016 November	23	6	29
2016 October	8	3	11

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