Skip to main content
OpenTrials
Completed

NCT Number: NCT02623894

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manuel A Gómez Marcos, Salamanca, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cardio-ankle vascular index

    Time frame: 2 years

    This parameter will be estimated using Vasera device VS-1500.

Secondary outcomes

  1. Brachial-ankle pulse wave velocity (ba-PWV)

    Time frame: 2 years

    This parameter will be estimated using Vasera device VS-1500.

  2. Ankle-brachial index

    Time frame: 2 years

    This parameter will be estimated using Vasera device VS-1500.

  3. Central augmentation index

    Time frame: 2 years

    This parameter will be estimated using the Sphygmo Cor System.

  4. Carotid Intima Media Thickness

    Time frame: 2 years

    A Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.

  5. Evaluation of retinal vessels

    Time frame: 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.

  6. Adherence to the mediterranean diet

    Time frame: 2 years

    Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.

  7. Objective measure of physical activity

    Time frame: 2 years

    It will be measured using Actigraph GT3X accelerometers.

  8. Self-reported physical activity

    Time frame: 2 years

    It will be measured using the International Physical Activity Questionnaire - Short Form.

  9. Sedentary time

    Time frame: 2 years

    It will be measured using the Questionnaire hours seated (Marshall).

  10. Subjective assessment of physical activity

    Time frame: 2 years

    It will be measured using the Paffenbarger Physical Activity Questionnaire.

  11. Carotid-femoral pulse wave velocity

    Time frame: 2 years

    This parameter will be estimated using the Sphygmo Cor System.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Collaborators

  • Castilla-León Health Service

Registry information

Official study title

Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2015
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.