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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37003
    • Primary care Research unit. La Alamedilla health centre
  • Salamanca, Spain, 37006
    • Manuel A Gómez Marcos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardio-ankle vascular index	This parameter will be estimated using Vasera device VS-1500.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial-ankle pulse wave velocity (ba-PWV)	This parameter will be estimated using Vasera device VS-1500.	2 years
Ankle-brachial index	This parameter will be estimated using Vasera device VS-1500.	2 years
Central augmentation index	This parameter will be estimated using the Sphygmo Cor System.	2 years
Carotid Intima Media Thickness	A Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.	2 years
Evaluation of retinal vessels	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.	2 years
Adherence to the mediterranean diet	Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.	2 years
Objective measure of physical activity	It will be measured using Actigraph GT3X accelerometers.	2 years
Self-reported physical activity	It will be measured using the International Physical Activity Questionnaire - Short Form.	2 years
Sedentary time	It will be measured using the Questionnaire hours seated (Marshall).	2 years
Subjective assessment of physical activity	It will be measured using the Paffenbarger Physical Activity Questionnaire.	2 years
Carotid-femoral pulse wave velocity	This parameter will be estimated using the Sphygmo Cor System.	2 years

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Castilla-León Health Service

Publications and helpful links

General Publications

• Gomez-Marcos MA, Martinez-Salgado C, Gonzalez-Sarmiento R, Hernandez-Rivas JM, Sanchez-Fernandez PL, Recio-Rodriguez JI, Rodriguez-Sanchez E, Garcia-Ortiz L. Association between different risk factors and vascular accelerated ageing (EVA study): study protocol for a cross-sectional, descriptive observational study. BMJ Open. 2016 Jun 7;6(6):e011031. doi: 10.1136/bmjopen-2016-011031.
• Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso C, Recio-Rodriguez JI, Alonso-Dominguez R, Sanchez-Aguadero N, Sanchez CL, Sanchez ER, Garcia-Ortiz L, Gomez-Marcos MA; on behalf EVA investigators. Reference values of central blood pressure and central haemodynamic parameters and their relationship with cardiovascular risk factors in a Spanish population: early vascular ageing study. J Hypertens. 2021 Nov 1;39(11):2147-2156. doi: 10.1097/HJH.0000000000002916.
• Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso MC, Alonso-Dominguez R, Sanchez-Aguadero N, Recio-Rodriguez JI, Gonzalez-Sanchez J, Garcia-Ortiz L, Gomez-Marcos MA; EVA group. Relationship of healthy vascular aging with lifestyle and metabolic syndrome in the general Spanish population. The EVA study. Rev Esp Cardiol (Engl Ed). 2021 Oct;74(10):854-861. doi: 10.1016/j.rec.2020.06.040. Epub 2020 Oct 31. English, Spanish.
• Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso MC, Cunha PG, Recio-Rodriguez JI, Alonso-Dominguez R, Sanchez-Aguadero N, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L, Gomez-Marcos MA; EVA Investigators. Vascular aging and its relationship with lifestyles and other risk factors in the general Spanish population: Early Vascular Ageing Study. J Hypertens. 2020 Jun;38(6):1110-1122. doi: 10.1097/HJH.0000000000002373.
• Gomez-Sanchez M, Patino-Alonso MC, Gomez-Sanchez L, Recio-Rodriguez JI, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L, Gomez-Marcos MA; EVA Group. Reference values of arterial stiffness parameters and their association with cardiovascular risk factors in the Spanish population. The EVA Study. Rev Esp Cardiol (Engl Ed). 2020 Jan;73(1):43-52. doi: 10.1016/j.rec.2019.04.016. Epub 2019 Sep 12. English, Spanish.
• Garcia-Ortiz L, Recio-Rodriguez JI, Agudo-Conde C, Maderuelo-Fernandez JA, Patino-Alonso MC, de Cabo-Laso A, Rodriguez-Martin C, Gonzalez-Sanchez J, Rodriguez-Sanchez E, Gomez-Marcos MA; on behalf the EVA Investigators group. Noninvasive validation of central and peripheral augmentation index estimated by a novel wrist-worn tonometer. J Hypertens. 2018 Nov;36(11):2204-2214. doi: 10.1097/HJH.0000000000001806.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Oxidative stress; Vascular aging.; Arterial stiffness.; Lifestyles.; Vascular structure.; Telomere length,; Psychological factors.; Inflammatory factors.
• Other Study ID Numbers: GRS 1193/B/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED