Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228459
Recruitment Status : Active, not recruiting
First Posted : July 25, 2017
Last Update Posted : August 7, 2019
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 Giráldez, Institut de Recerca Biomèdica de Lleida

Brief Summary:

BACKGROUND AND OBJECTIVES:

Cardiovascular disease is the leading cause of death despite huge primary and secondary prevention policies with a strong economic burden. The primary objectives of the ILERVAS project are: (i) to identify unknown factors involved in the presence of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (ii) to identify unknown factors involved in the progression of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (iii) to Assess of the impact of arterial ultrasound on cardiovascular events and mortality in a low/moderate cardiovascular risk population.

METHODS:

Randomized intervention study. From 2015 to 2018, 16,660 participants (8,330 in the intervention group (Mobile Unit Follow-up Group) and 8,330 in the no intervention group (Electronic Medical History Follow-up 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 across the province of Lleida, Spain.


Condition or disease Intervention/treatment Phase
Atherosclerosis Chronic Kidney Diseases Metabolic Syndrome PreDiabetes Subclinical Disease and/or Syndrome Diagnostic Test: Dried blood spot test Diagnostic Test: Urine test 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: Biological sample collection Other: Result and recommendation report Diagnostic Test: Pulse wave velocity Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized interventional study with 2 arms that will include 16,660 individuals with at least one cardiovascular risk factor from the province of Lleida, Spain. Patients will be recruited from January 2015 to December 2018. Patients will be followed for 10 years.
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile Unit Follow-up Group
In the Mobile Unit (MU), clinical, sociodemographic and anthropometric data will be recorded. Patients will be evaluated with artery ultrasound (carotid, femoral, transcranial and abdominal aorta), ankle-brachial index, pulse wave velocity, spirometry, determination of advanced glycation-end products, atrial fibrillation screening, dried blood spot test and urine analysis. Moreover, DNA, RNA, Saliva, blood and urine samples will be collected and stored in the biobank to identify new biomarkers using omic studies. Additionally, climate, air pollutant and airborne pollen data form the entire province of Lleida will be registered. 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.
Diagnostic Test: Dried blood spot test
Dried capillary blood testing creatinine, uric acid and total cholesterol (reflotron® 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 test
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 (Diagnostics, 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: Biological sample collection
Blood samples from a peripheral vein of the hand or forearm to obtain serum, plasma, DNA and RNA will be collected. Moreover, a saliva sample 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: Result and recommendation report
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.

Diagnostic Test: Pulse wave velocity
Pulse wave velocity (PWV) will be used as an indicator of arterial stiffness. It will be measured non-invasively with the carotid to femoral PWV (cfPWV) according to standard protocols.

No Intervention: Electronic Medical History Follow-up Group
Participants will be followed through their electronic medical records. Sociodemographic (age, sex, race, marital status, education and labour status), clinical and anthropometric data and will be electronically collected.



Primary Outcome Measures :
  1. Identification of sociodemographic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in atherosclerosis, in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    The presence of atherosclerosis will be identified as an intima-media thickness higher than 1.5 mm.

  2. Identification of sociodemographic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in pre-diabetes, in a low/moderate cardiovascular risk population. [ Time Frame: 4 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.

  3. Identification of sociodemograpic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in chronic kidney disease, in a low/moderate cardiovascular risk population. [ Time Frame: 4 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.

  4. Assessment of the impact of arterial ultrasound 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 atherosclerosis in a low/moderate cardiovascular risk population [ Time Frame: 4 years ]
    The presence of atherosclerosis will be identified as an intima-media thickness higher than 1.5 mm.

  2. Prevalence of hidden chronic kidney disease in a low/moderate cardiovascular risk population. [ Time Frame: 4 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: 4 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. Correlation of skin autofluorescence with atherosclerosis in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    Skin autofluorescence will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units.

  5. Correlation of adherence to the Mediterranean diet with atherosclerosis in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    Adherence to the Mediterranean diet will be evaluated with the Mediterranean Diet Adherence screener (MEDAS). Values are from 0 to 14 and categorize subjects according to their level of adherence: high (score >11 points), moderate (7-10 points), and low (<6 points).

  6. Correlation of physical exercise with atherosclerosis in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). Values are from vigorous, moderate, and low physical activity. Low activity corresponds to no activity or some activity but not enough to meet moderate category. Moderate corresponds to 3 or more days of walking for at least 30 minutes. Vigorous activity corresponds to 5 or more days of walking for at least 60 minutes.

  7. Prevalence of atrial fibrillation in a low/moderate cardiovascular risk population. [ Time Frame: 4 years ]
    The presence of atrial fibrillation is assessed with stroke risk analysis device (SRA, EVINA Health Solutions).

  8. Correlation of spirometry alterations with atherosclerosis in a low/moderate cardiovascular risk population [ Time Frame: 4 years ]
    Forced vital capacity (FVC) will be measured as liters (l).

  9. Correlation of advanced glycation end-products (AGEs) and cardiovascular events in a low/moderate cardiovascular risk population. [ Time Frame: 10 years ]
    AGES will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units.

  10. Correlation 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 Mediterranean Diet Adherence screener (MEDAS). Values are from 0 to 14 and categorize subjects according to their level of adherence: high (score >11 points), moderate (7-10 points), and low (<6 points).

  11. Correlation 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). Values are from vigorous, moderate, and low physical activity.

  12. Association of spirometry alterations and cardiovascular events in a low/moderate cardiovascular risk population [ Time Frame: 10 years ]
    Forced vital capacity (FVC) will be measured as liters (l).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 >30 Kg/m2), current smoking habit or former smoker (<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 < 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


Locations
Layout table for location information
Spain
Fundació Renal Jaume Arnò
Lleida, Spain, 25006
Primary Care centre
Lleida, Spain, 25007
Institut de recerca Biomèdica de Lleida
Lleida, Spain, 25198
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
Layout table for investigator information
Study Chair: Elvira Fernández Giráldez, MD, PhD Fundació Renal Jaume Arnò
Study Director: Marcelino Bermúdez López, MD, PhD Institut de Recerca Biomèdica de Lleida

Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Elvira Fernández Giráldez, Study Chair, Institut de Recerca Biomèdica de Lleida
ClinicalTrials.gov Identifier: NCT03228459    
Other Study ID Numbers: The ILERVAS project
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elvira Fernández Giráldez, 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:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Atherosclerosis
Vascular Diseases
Metabolic Syndrome
Prediabetic State
Syndrome
Disease
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases