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The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease (ILERVAS)

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ClinicalTrials.gov Identifier: NCT03228459
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
Diputació de Lleida
Jaume Arnó Renal Foundation
Unit of Detection and Treatment of Atherothrombotic diseases (UDETMA)
Lleida Primary health care
Information provided by (Responsible Party):
Elvira Fernández Girálde, Institut de Recerca Biomèdica de Lleida

Brief Summary:

Background and Objectives: Chronic 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 with clinical data, vascular imaging and biological samples to define a personalized cardiovascular risk profile.

Methods: Randomized intervention study. From 2015 to 2017, 14,600 people (7,300 in the intervention group and 7,300 in the control group) aged between 45 and 70 years without a previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected from the primary health care centers across the province of Lleida, Spain. 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, atrial fibrillation screening, 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 2027 to assess whether the intervention group has any changes on medical treatments and lifestyle changes. In addition, the incidence of cardiovascular events will be compared between the intervention and control groups.


Condition or disease Intervention/treatment Phase
Kidney Diseases Subclinical Disease and/or Syndrome Atherosclerosis Early Diagnosis Ultrasound Other: Clinical data collection Diagnostic Test: Dried blood spot Diagnostic Test: Urine spot tests Diagnostic Test: Artery ultrasound Diagnostic Test: Ankle-brachial index Diagnostic Test: Spirometry Diagnostic Test: Determination of advanced glycation end products Diagnostic Test: Atrial fibrillation screening Other: Biobank Other: Exploration results and recommendations Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized interventional study with 2 arms that will include 14,600 individuals with at least one CV risk factor, registered in Primary care in the province of Lleida, between January 2015 and December 2017, who will subsequently be followed up until December 2027.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Intervention Study to Assess the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease and Its Impact on Morbidity and Mortality: The ILERVAS Project
Actual Study Start Date : January 15, 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
In the MU, besides clinical data collection, dried blood spot and urine spot tests, patients will be evaluated with artery ultrasound (carotid, femoral, transcranial and abdominal aorta), ankle-brachial index, spirometry, determination of advanced glycation end products and atrial fibrillation screening. Additionally, blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omic studies. Finally, a report with the exploration results and recommendations based on the current guidelines will be uploaded to the e-CAP history for the Primary care evaluation.
Other: Clinical data collection
Sociodemographic variables (age, sex and race), medical history of comorbidities and medical treatments will be collected from the electronic Primary Care medical history (e-CAP). The following variables will be recorded in the MU: weight, height, waist circumference and neck circumference, body mass index in kg/m2, hours of fasting, systolic blood pressure, diastolic blood pressure and pulse pressure (mmHg). Blood pressure will be measured 3 times (Omron 6) at 2-min intervals and the mean of the last 2 will be collected. In addition, variables related to physical exercise (International Physical Activity Questionnaire (IPAQ)), diet (adapted from the PREDIMED study), and variables daytime somnolence (the Berlin Questionnaire and the Epworth somnolence scale).

Diagnostic Test: Dried blood spot
Dried capillary blood testing creatinine, uric acid and total cholesterol (Reflotrons® Plus system, Roche). Determination of the complete lipid profile in cases in which total cholesterol is greater than 200 mg/dl: HDL cholesterol (mg/dl), LDL cholesterol (mg/dl) and triglycerides (mg/dl) (Cobas B 101® system, Roche). Calculation of non-HDL cholesterol levels. Glycated haemoglobin will be analysed with the Cobas B 101 system,Roche. The CKD-EPI glomerular filtration rate will be determined.

Diagnostic Test: Urine spot tests
A urine sample from spontaneous micturition will be collected and analyzed using Clinitek Microalbumin 2 Reagent Strips and a Siemens Clinitek Status® analyzer. It will be determined albuminuria (mg/l) and albumin/creatinine ratio (mg/g).

Diagnostic Test: Artery ultrasound
Carotid and femoral artery ultrasound for atheroma plaque diagnosis. Abdominal aorta ultrasound for early diagnosis of aortic aneurism. Transcranial ultrasound for cerebral arterial blood flow alterations.

Diagnostic Test: Ankle-brachial index
Systolic blood pressure measurement 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.

Diagnostic Test: Spirometry
Spirometry 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.

Diagnostic Test: Determination of advanced glycation end products
These 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.

Diagnostic Test: Atrial fibrillation screening
The presence of atrial fibrillation is assessed with a device (SRA, EVINA Health Solutions) during one hour in the mobile unit.

Other: Biobank
Blood samples from a peripheral vein of the hand or forearm to obtain serum, plasma, DNA and RNA will be collected. These samples will be prepared in aliquots following a standardized protocol, and sent frozen (dry ice) to a centralized biobank (IRBLleida Biobank, Spain) for processing and storage for subsequent studies of CV, inflammatory and mineral-metabolism biomarkers and genetic polymorphisms. Urine samples will be frozen and stored in a biobank for subsequent study of biomarkers.

Other: Exploration results and recommendations
A report with exploration results and recommendations based on the current guidelines will be uploaded to the e-CAP history for the Primary care evaluation.

No Intervention: Control group
Patients will be evaluated in primary care units only according to their cardiovascular risk scores.



Primary Outcome Measures :
  1. Impact of the intervention on cardiovascular events and mortality in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10). Cardiovascular events and mortality in the intervention group will be compared to the control group during a during a 10-year follow-up period.


Secondary Outcome Measures :
  1. Prevalence of subclinical atherosclerosis in a low/moderate cardiovascular risk population [ Time Frame: 3 years ]
    The prevalence of subclinical atherosclerosis will be evaluated in the intervention group. The presence of an atheromatous plaque will be identified as an intima-media thickness higher than 1.5 mm. The degree of stenosis (<50%, 50-70% or 70-99%) will be quantified by colour and pulsed Doppler. In addition, the systolic velocity peak (SVP in cm/s), diastolic velocity peak (DVP cm/s) will be quantified.

  2. Prevalence of hidden chronic kidney disease in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    The prevalence of hidden chronic kidney disease will be assessed with a urine spot test that determines the albumin/creatinine ratio (ACR). Values lower than 30 mg/g are normal; 30-300 mg/g indicate microalbuminuria; and values higher than 300 indicate macroalbuminuria.

  3. Prevalence of pre-diabetes and undiagnosed diabetes in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    The percentage of glycated hemoglobin (Hb A1c) will be determined with a Cobas b 101® machine (Roche). Values lower than 5.7% are normal; 5.7-6.5% indicate pre-diabetes; and ≥ 6.5% indicate diabetes.

  4. Association of advanced glycation end-products (AGEs) with atheromatous disease in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    The relationship between the AGES and the presence of atheromatous plaques will be evaluated quantifying the skin autofluorescence (SAF). SAF will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values are expressed in arbitrary units and calibrated according to manufacturer's instructions.

  5. Association of adherence to the Mediterranean diet with atheromatous disease in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    Adherence to the Mediterranean diet will be evaluated with the diet survey adapted from the PREDIMED study. This survey has been previously validated in the Spanish population.

  6. Characterization of new early lipidomic biomarkers of atherosclerosis in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    Blood samples will be analyzed to describe new lipid biomarkers associated with the presence of atheromatous plaque.

  7. Association of physical exercise with atheromatous disease in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). The association between physical exercise and the presence on atheromatous plaque will be evaluated

  8. Prevalence of atrial fibrillation in a low/moderate cardiovascular risk population. [ Time Frame: 3 years ]
    The presence of atrial fibrillation is assessed with stroke risk analysis device (SRA, EVINA Health Solutions).

  9. Association of spirometry alterations and atheromatous plaque in a low/moderate cardiovascular risk population [ Time Frame: 3 years ]
    Spirometry 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.

  10. Changes induced by the report generated in the Mobile Unit in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    The mobile Unit generates a personal report with results and recommendations. This report will be sent to the Primary Care doctor. The impact of this report will be evaluated as changes in medical treatment (new prescriptions or adjustment in previous prescriptions).

  11. Association of advanced glycation end-products (AGEs) and cardiovascular events in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    The relationship between the AGES and cardiovascular events will be evaluated quantifying the skin autofluorescence (SAF). SAF will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values are expressed in arbitrary units and calibrated according to manufacturer's instructions. The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10).

  12. Association of adherence to the Mediterranean diet and cardiovascular events in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    Adherence to the Mediterranean diet will be evaluated with the diet survey adapted from the PREDIMED study. This survey has been previously validated in the Spanish population. The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10).

  13. Association of physical exercise and cardiovascular events in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). The association between physical exercise and cardiovascular events will be evaluated. The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10).

  14. Characterization of new early lipidomic biomarkers of cardiovascular events in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    Blood samples will be analyzed to describe new lipid biomarkers associated with cardiovascular events. The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10).

  15. Association of spirometry alterations and cardiovascular events in a low/moderate cardiovascular risk population [ Time Frame: 10 years ]
    Spirometry 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. The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10).



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women (50-70 years) and men ( 45-65 years) with at least one cardiovascular risk factor (hypertension, dyslipidemia, obesity (BMI>30Kg/m2), current smoking habit or former smoker in less than 10 years, first-degree family history of early cardiovascular disease).

Exclusion Criteria:

  • Prior medical history of cardiovascular disease.
  • Diabetes.
  • Glomerular filtration rate (CKD-EPI) < 60 ml/min(1.73m2).
  • Active neoplasm or acute disease.
  • A life expectancy shorter than 18 months.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228459


Contacts
Contact: Àngels Betriu Bars 0034973702481 ext 2481 abetriu@irblleida.cat
Contact: Jose Manuel Valdivielso Revilla 0034973703650 ext 3650 valdivielso@medicina.udl.cat

Locations
Spain
Primary Care centre Recruiting
Lleida, Spain, 25007
Contact: Cristina Farrás Salles    0034661343421    cfarras.lleida.ics@gencat.cat   
Contact: Marcelino Bermudez Lopez    0034973702482 ext 2482    mbermudez@irblleida.cat   
Institut de recerca Biomèdica de Lleida Recruiting
Lleida, Spain, 25198
Contact: Àngels Betriu Bars    0034973702481 ext 2481    abetriu@irblleida.cat   
Contact: Jose Manuel Valdivielso Revilla    0034973703560 ext 3560    valdivielso@medicina.udl.cat   
Principal Investigator: Ferran Barbé Illa         
Principal Investigator: Manuel Portero Otín         
Principal Investigator: Francisco Purroy Garcia         
Principal Investigator: Albert Lecube Torelló         
Sponsors and Collaborators
Institut de Recerca Biomèdica de Lleida
Diputació de Lleida
Jaume Arnó Renal Foundation
Unit of Detection and Treatment of Atherothrombotic diseases (UDETMA)
Lleida Primary health care
Investigators
Study Chair: Elvira Fernandez Guiráldez Institut de Recerca Biomèdica de Lleida
Study Director: Àngels Betriu Bars Institut de Recerca Biomèdica de Lleida
Principal Investigator: Jose Manuel Valdivielso Revilla Institut de Recerca Biomèdica de Lleida
Principal Investigator: Marcelino Bermúdez López Institut de Recerca Biomèdica de Lleida
Principal Investigator: David Arroyo Rueda Institut de Recerca Biomèdica de Lleida

Additional Information:
Publications:
Responsible Party: Elvira Fernández Girálde, IRBLleida's Director, Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT03228459     History of Changes
Other Study ID Numbers: The ILERVAS project
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elvira Fernández Girálde, Institut de Recerca Biomèdica de Lleida:
Kidney Diseases
Subclinical Disease and/or Syndrome
Atherosclerosis
Biomarkers
Prevention
Lung capacity
Early diagnosis
Advanced glycation end products
Atrial fibrillation
Diabetes
Arterial ultrasound

Additional relevant MeSH terms:
Kidney Diseases
Atherosclerosis
Vascular Diseases
Urologic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases