Influence of Different Risk Factors in Vascular Accelerated Aging (EVA Study)
Condition: Healthy
Study type: Observational [Patient Registry]

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.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
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.
      
Biospecimen description: 
      Fasting plasma glucose, creatinine, uric acid, Ca, P, serum total cholesterol, high-density
      lipoprotein cholesterol and triglyceride levels will be measured using standard enzymatic
      automated methods. Low-density lipoprotein cholesterol will be estimated by the Friedewald
      equation when the direct parameter is not available. Glycated haemoglobin will be measured
      with an immune-turbidimetric assay. Cytokines concentrations in plasma will be determined by
      ELISA using commercial kits and following the manufacturer's recommendations. Oxidative
      stress will be determined by measuring lipid peroxides and nucleic acid derivatives by ELISA
      using commercial kits and following the manufacturer's recommendations.
    
Keywords: Vascular aging.; Arterial stiffness.; Lifestyles.; Vascular structure.; Telomere length,; Psychological factors.; Inflammatory factors.; Oxidative stress