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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623894
• Other study ID #: GRS 1193/B/15
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2020
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Spain	Manuel A Gómez Marcos	Salamanca
Spain	Primary care Research unit. La Alamedilla health centre	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Gomez-Marcos MA, Martinez-Salgado C, Gonzalez-Sarmiento R, Hernandez-Rivas JM, Sanchez-Fernandez PL, Recio-Rodriguez JI, Rodriguez-Sanchez E, García-Ortiz L. Association between different risk factors and vascular accelerated ageing (EVA study): study pro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardio-ankle vascular index	This parameter will be estimated using Vasera device VS-1500.	2 years
Secondary	Brachial-ankle pulse wave velocity (ba-PWV)	This parameter will be estimated using Vasera device VS-1500.	2 years
Secondary	Ankle-brachial index	This parameter will be estimated using Vasera device VS-1500.	2 years
Secondary	Central augmentation index	This parameter will be estimated using the Sphygmo Cor System.	2 years
Secondary	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
Secondary	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
Secondary	Adherence to the mediterranean diet	Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.	2 years
Secondary	Objective measure of physical activity	It will be measured using Actigraph GT3X accelerometers.	2 years
Secondary	Self-reported physical activity	It will be measured using the International Physical Activity Questionnaire - Short Form.	2 years
Secondary	Sedentary time	It will be measured using the Questionnaire hours seated (Marshall).	2 years
Secondary	Subjective assessment of physical activity	It will be measured using the Paffenbarger Physical Activity Questionnaire.	2 years
Secondary	Carotid-femoral pulse wave velocity	This parameter will be estimated using the Sphygmo Cor System.	2 years