Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cardio-ankle vascular index
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 35 to 75 years who agree to participate in the study and do not meet any of the exclusion criteria.
排除标准
- •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.
结局指标
主要结局
Cardio-ankle vascular index
时间窗: 2 years
This parameter will be estimated using Vasera device VS-1500.
次要结局
- Ankle-brachial index(2 years)
- Central augmentation index(2 years)
- Self-reported physical activity(2 years)
- Subjective assessment of physical activity(2 years)
- Carotid-femoral pulse wave velocity(2 years)
- Evaluation of retinal vessels(2 years)
- Adherence to the mediterranean diet(2 years)
- Carotid Intima Media Thickness(2 years)
- Objective measure of physical activity(2 years)
- Sedentary time(2 years)
- Brachial-ankle pulse wave velocity (ba-PWV)(2 years)