Influence of Different Risk Factors in Vascular Accelerated Aging (EVA Study)
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|ClinicalTrials.gov Identifier: NCT02623894|
Recruitment Status : Unknown
Verified November 2015 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud.
Recruitment status was: Recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
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.
|Condition or disease|
The general objectives of this study are: To establish reference values for vascular structure and function in the population of Salamanca.
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.
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).
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2017|
- Cardio-ankle vascular index [ Time Frame: 2 years ]This parameter will be estimated using Vasera device VS-1500.
- Brachial-ankle pulse wave velocity (ba-PWV) [ Time Frame: 2 years ]This parameter will be estimated using Vasera device VS-1500.
- Ankle-brachial index [ Time Frame: 2 years ]This parameter will be estimated using Vasera device VS-1500.
- Central augmentation index [ Time Frame: 2 years ]This parameter will be estimated using the Sphygmo Cor System.
- 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.
- 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.
- 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.
- Objective measure of physical activity [ Time Frame: 2 years ]It will be measured using Actigraph GT3X accelerometers.
- Self-reported physical activity [ Time Frame: 2 years ]It will be measured using the International Physical Activity Questionnaire - Short Form.
- Sedentary time [ Time Frame: 2 years ]It will be measured using the Questionnaire hours seated (Marshall).
- Subjective assessment of physical activity [ Time Frame: 2 years ]It will be measured using the Paffenbarger Physical Activity Questionnaire.
- Carotid-femoral pulse wave velocity [ Time Frame: 2 years ]This parameter will be estimated using the Sphygmo Cor System.
Biospecimen Retention: Samples Without DNA
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): NCT02623894
|Contact: Manuel A Gomez-Marcosemail@example.com|
|Contact: Luis Garcia-Ortizfirstname.lastname@example.org|
|Primary care Research unit. La Alamedilla health centre||Recruiting|
|Salamanca, Spain, 37003|
|Contact: Jose I Recio 0034 923124465 Lgarciao@usal.es|
|Principal Investigator: Manuel A Gomez Marcos, MD|
|Sub-Investigator: Luis Garcia Ortiz, MD|
|Sub-Investigator: José I Recio Rodríguez|
|Sub-Investigator: Yolanda Castaño Sánchez|
|Sub-Investigator: Emiliano Rodríguez Sanchez, MD|
|Sub-Investigator: Angel de Cabo Laso|
|Sub-Investigator: Benigna Sanchez Salgado|
|Manuel A Gómez Marcos||Completed|
|Salamanca, Spain, 37006|