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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 16,660
- Locations
- 6
- Primary Endpoint
- Identification of sociodemographic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in pre-diabetes, in a low/moderate cardiovascular risk population.
Study Overview
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.
Detailed Description
STUDY DESIGN AND POPULATION:
Randomized interventional 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. The Ethics Committee of the University Hospital Arnau de Vilanova in Lleida (Spain) approved the protocol. All patients signed informed consent. The study was conducted according to the principles of the Declaration of Helsinki.
SOURCE OF INFORMATION AND INSTRUMENTS FOR DATA COLLECTION:
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. In addition, variables such as physical exercise, diet and daytime will be collected.
In the no intervention group (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Result and recommendation report (Other)
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.
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.
Intervention: Biological sample collection (Other)
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.
Intervention: Dried blood spot test (Diagnostic Test)
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.
Intervention: Urine test (Diagnostic Test)
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.
Intervention: Artery ultrasound (Diagnostic Test)
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.
Intervention: Ankle-brachial index (Diagnostic Test)
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.
Intervention: Spirometry (Diagnostic Test)
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.
Intervention: Determination of advanced glycation-end products (Diagnostic Test)
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.
Intervention: Atrial fibrillation screening (Diagnostic Test)
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.
Intervention: Pulse wave velocity (Diagnostic Test)
Outcomes
Primary Outcomes
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.
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.
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.
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 Outcomes
- Prevalence of hidden chronic kidney disease in a low/moderate cardiovascular risk population.(4 years)
- Correlation of adherence to the Mediterranean diet with atherosclerosis in a low/moderate cardiovascular risk population.(4 years)
- Correlation of adherence to the Mediterranean diet and cardiovascular events in a low/moderate cardiovascular risk population.(10 years)
- Prevalence of atrial fibrillation in a low/moderate cardiovascular risk population.(4 years)
- Prevalence of atherosclerosis in a low/moderate cardiovascular risk population(4 years)
- Correlation of spirometry alterations with atherosclerosis in a low/moderate cardiovascular risk population(4 years)
- Correlation of advanced glycation end-products (AGEs) and cardiovascular events in a low/moderate cardiovascular risk population.(10 years)
- Correlation of physical exercise and cardiovascular events in a low/moderate cardiovascular risk population.(10 years)
- Prevalence of pre-diabetes and undiagnosed diabetes in a low/moderate cardiovascular risk population.(4 years)
- Association of spirometry alterations and cardiovascular events in a low/moderate cardiovascular risk population(10 years)
- Correlation of skin autofluorescence with atherosclerosis in a low/moderate cardiovascular risk population.(4 years)
- Correlation of physical exercise with atherosclerosis in a low/moderate cardiovascular risk population.(4 years)
Investigators
Elvira Fernández Giráldez
Study Chair
Institut de Recerca Biomèdica de Lleida