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

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ClinicalTrials.gov Identifier: NCT02623894
Recruitment Status : Unknown
Verified November 2015 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud.
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Castilla-León Health Service
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.


Condition or disease
Healthy

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 [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)
Study Start Date : October 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. Cardio-ankle vascular index [ Time Frame: 2 years ]
    This parameter will be estimated using Vasera device VS-1500.


Secondary Outcome Measures :
  1. Brachial-ankle pulse wave velocity (ba-PWV) [ Time Frame: 2 years ]
    This parameter will be estimated using Vasera device VS-1500.

  2. Ankle-brachial index [ Time Frame: 2 years ]
    This parameter will be estimated using Vasera device VS-1500.

  3. Central augmentation index [ Time Frame: 2 years ]
    This parameter will be estimated using the Sphygmo Cor System.

  4. Carotid Intima Media Thickness [ Time Frame: 2 years ]
    A Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.

  5. Evaluation of retinal vessels [ Time Frame: 2 years ]
    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.

  6. Adherence to the mediterranean diet [ Time Frame: 2 years ]
    Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.

  7. Objective measure of physical activity [ Time Frame: 2 years ]
    It will be measured using Actigraph GT3X accelerometers.

  8. Self-reported physical activity [ Time Frame: 2 years ]
    It will be measured using the International Physical Activity Questionnaire - Short Form.

  9. Sedentary time [ Time Frame: 2 years ]
    It will be measured using the Questionnaire hours seated (Marshall).

  10. Subjective assessment of physical activity [ Time Frame: 2 years ]
    It will be measured using the Paffenbarger Physical Activity Questionnaire.

  11. Carotid-femoral pulse wave velocity [ Time Frame: 2 years ]
    This parameter will be estimated using the Sphygmo Cor System.


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623894


Contacts
Contact: Manuel A Gomez-Marcos 0034923231859 magomez@usal.es
Contact: Luis Garcia-Ortiz 0034923231859 lgarciao@usal.es

Locations
Spain
Primary care Research unit. La Alamedilla health centre Recruiting
Salamanca, Spain, 37003
Contact: Jose I Recio    0034 923124465    Lgarciao@usal.es   
Principal Investigator: Manuel A Gomez Marcos, MD         
Sub-Investigator: Luis Garcia Ortiz, MD         
Sub-Investigator: José I Recio Rodríguez         
Sub-Investigator: Yolanda Castaño Sánchez         
Sub-Investigator: Emiliano Rodríguez Sanchez, MD         
Sub-Investigator: Angel de Cabo Laso         
Sub-Investigator: Benigna Sanchez Salgado         
Manuel A Gómez Marcos Completed
Salamanca, Spain, 37006
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Castilla-León Health Service

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02623894     History of Changes
Other Study ID Numbers: GRS 1193/B/15
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: November 2015

Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Vascular aging.
Arterial stiffness.
Lifestyles.
Vascular structure.
Telomere length,
Psychological factors.
Inflammatory factors.
Oxidative stress