Influence of Different Risk Factors in Vascular Accelerated Aging (EVA Study)

Completed

• Conditions: Healthy

• Registration Number: NCT02623894
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Brief Summary

Introduction: The process of population aging that is occurring in developed societies represents a major challenge for the health system. The aim of this study is to analyze factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine differences by gender in a Spanish population.

Methods and analysis: An observational, descriptive, cross sectional study.

Study Population: From the population assigned to the participating Health Care centers, a cluster random sampling stratified by age and gender will be performed to obtain 500 participants aged between 35 and 75. Those who meet the inclusion criteria and give written informed consent will be included in the study.

Measurements: Main dependent variables: cf-PWV determined using Sphigmo Cor System and CAVI estimated using VASERA. Secondary dependent variables: telomere length, carotid intima-media thickness, central and peripheral augmentation index, ankle-brachial pulse wave velocity, ankle-brachial index, retinal arteriovenous index, and renal and cardiac organ damage. Independent variables: Lifestyles (physical activity, adherence to mediterranean diet, alcohol and tobacco consumption); psychological factors (depression, anxiety, and chronic stress); inflammatory factors and oxidative stress.

Ethics and dissemination: The study has been approved by the clinical research ethics committee of the healthcare area of Salamanca. All study participants will sign an informed consent to agree to participate in the study in compliance with the Declaration of Helsinki and the WHO standards for observational studies. The results of this study will allow the understanding of the relationship of the different influencing factors and their relative weight in the development of EVA. At least five publications in first-quartile scientific journals are planned.

Detailed Description

The general objectives of this study are: To establish reference values for vascular structure and function in the population of Salamanca.

Study design:

A cross-sectional, descriptive observational study. The investigators consider subjects with EVA as those having cf-PWV and/or CAVI values greater than the 75th percentile.

Study setting:

To be implemented in the Research Unit of La Alamedilla Primary Care Center, and on the premises of the Hospital and University of Salamanca of the eight participating groups from the Biomedical Research Institute of Salamanca (IBSAL).

Study population:

It will be the urban population attached to the Health Center of Salamanca. Using a random sampling stratified by age groups (35, 45, 55, 65 and 75 years) and gender, 100 subjects will be selected in each group (50 males and 50 females), aged 35 to 75 years.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients aged 35 to 75 years who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria

• Subjects who are in terminal condition, who cannot travel to the health centers to undergo the corresponding examinations, and those who do not wish to sign the informed consent.
• Subjects with a history of CVD (ischemic heart disease or stroke, peripheral arterial disease or heart failure), diagnosed renal failure in terminal stages (glomerular filtration rate below 30%), chronic inflammatory disease, or acute inflammatory process in the past three months.
• Patients treated with estrogens, testosterone, or growth hormone.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardio-ankle vascular index	2 years	This parameter will be estimated using Vasera device VS-1500.

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial index	2 years	This parameter will be estimated using Vasera device VS-1500.
Central augmentation index	2 years	This parameter will be estimated using the Sphygmo Cor System.
Self-reported physical activity	2 years	It will be measured using the International Physical Activity Questionnaire - Short Form.
Subjective assessment of physical activity	2 years	It will be measured using the Paffenbarger Physical Activity Questionnaire.
Carotid-femoral pulse wave velocity	2 years	This parameter will be estimated using the Sphygmo Cor System.
Sedentary time	2 years	It will be measured using the Questionnaire hours seated (Marshall).
Carotid Intima Media Thickness	2 years	A Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.
Objective measure of physical activity	2 years	It will be measured using Actigraph GT3X accelerometers.
Evaluation of retinal vessels	2 years	Retinography will be performed using a Topcon TRC NW 200 non-mydriatic retinal camera (Topcon Europe B.C., Capelle a/d Ijssel, The Netherlands), obtaining nasal and temporal images centered on the disk.
Adherence to the mediterranean diet	2 years	Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.
Brachial-ankle pulse wave velocity (ba-PWV)	2 years	This parameter will be estimated using Vasera device VS-1500.

Trial Locations

Locations (2)

Primary care Research unit. La Alamedilla health centre; 🇪🇸 Salamanca, Spain

Manuel A Gómez Marcos; 🇪🇸 Salamanca, Spain