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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02623894
Enrollment
500
Registered
2015-12-08
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Vascular aging., Arterial stiffness., Lifestyles., Vascular structure., Telomere length,, Psychological factors., Inflammatory factors., Oxidative stress

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 35 to 75 years who agree to participate in the study and do not meet any of the

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
Cardio-ankle vascular index2 yearsThis parameter will be estimated using Vasera device VS-1500.

Secondary

MeasureTime frameDescription
Carotid Intima Media Thickness2 yearsA Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.
Ankle-brachial index2 yearsThis parameter will be estimated using Vasera device VS-1500.
Central augmentation index2 yearsThis parameter will be estimated using the Sphygmo Cor System.
Evaluation of retinal vessels2 yearsRetinography 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 diet2 yearsPrincipal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.
Brachial-ankle pulse wave velocity (ba-PWV)2 yearsThis parameter will be estimated using Vasera device VS-1500.
Self-reported physical activity2 yearsIt will be measured using the International Physical Activity Questionnaire - Short Form.
Sedentary time2 yearsIt will be measured using the Questionnaire hours seated (Marshall).
Subjective assessment of physical activity2 yearsIt will be measured using the Paffenbarger Physical Activity Questionnaire.
Carotid-femoral pulse wave velocity2 yearsThis parameter will be estimated using the Sphygmo Cor System.
Objective measure of physical activity2 yearsIt will be measured using Actigraph GT3X accelerometers.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026