Clinical trial NCT02623894: Influence of Different Risk Factors in Vascular Accelerated Aging (EVA Study)
Official title: Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Vascular aging.
Arterial stiffness.
Lifestyles.
Vascular structure.
Telomere length,
Psychological factors.
Inflammatory factors.
Oxidative stress
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2015-12-08
Enrollment: 500
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

Eligibility 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.

Primary outcomes:
measure: Cardio-ankle vascular index
timeFrame: 2 years
Secondary outcomes:
measure: Brachial-ankle pulse wave velocity (ba-PWV)
timeFrame: 2 years
measure: Ankle-brachial index
timeFrame: 2 years
measure: Central augmentation index
timeFrame: 2 years
measure: Carotid Intima Media Thickness
timeFrame: 2 years
measure: Evaluation of retinal vessels
timeFrame: 2 years
measure: Adherence to the mediterranean diet
timeFrame: 2 years
measure: Objective measure of physical activity
timeFrame: 2 years
measure: Self-reported physical activity
timeFrame: 2 years
measure: Sedentary time
timeFrame: 2 years
measure: Subjective assessment of physical activity
timeFrame: 2 years
measure: Carotid-femoral pulse wave velocity
timeFrame: 2 years
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary care Research unit. La Alamedilla health centre
city: Salamanca
country: Spain
facility: Manuel A Gómez Marcos
Study officials:
References:
citation: Gomez-Marcos MA, Martinez-Salgado C, Gonzalez-Sarmiento R, Hernandez-Rivas JM, Sanchez-Fernandez PL, Recio-Rodriguez JI, Rodriguez-Sanchez E, Garcia-Ortiz L. Association between different risk factors and vascular accelerated ageing (EVA study): study protocol for a cross-sectional, descriptive observational study. BMJ Open. 2016 Jun 7;6(6):e011031. doi: 10.1136/bmjopen-2016-011031.
citation: Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso C, Recio-Rodriguez JI, Alonso-Dominguez R, Sanchez-Aguadero N, Sanchez CL, Sanchez ER, Garcia-Ortiz L, Gomez-Marcos MA; on behalf EVA investigators. Reference values of central blood pressure and central haemodynamic parameters and their relationship with cardiovascular risk factors in a Spanish population: early vascular ageing study. J Hypertens. 2021 Nov 1;39(11):2147-2156. doi: 10.1097/HJH.0000000000002916.
citation: Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso MC, Alonso-Dominguez R, Sanchez-Aguadero N, Recio-Rodriguez JI, Gonzalez-Sanchez J, Garcia-Ortiz L, Gomez-Marcos MA; EVA group. Relationship of healthy vascular aging with lifestyle and metabolic syndrome in the general Spanish population. The EVA study. Rev Esp Cardiol (Engl Ed). 2021 Oct;74(10):854-861. doi: 10.1016/j.rec.2020.06.040. Epub 2020 Oct 31. English, Spanish.
citation: Gomez-Sanchez M, Gomez-Sanchez L, Patino-Alonso MC, Cunha PG, Recio-Rodriguez JI, Alonso-Dominguez R, Sanchez-Aguadero N, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L, Gomez-Marcos MA; EVA Investigators. Vascular aging and its relationship with lifestyles and other risk factors in the general Spanish population: Early Vascular Ageing Study. J Hypertens. 2020 Jun;38(6):1110-1122. doi: 10.1097/HJH.0000000000002373.
citation: Gomez-Sanchez M, Patino-Alonso MC, Gomez-Sanchez L, Recio-Rodriguez JI, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L, Gomez-Marcos MA; EVA Group. Reference values of arterial stiffness parameters and their association with cardiovascular risk factors in the Spanish population. The EVA Study. Rev Esp Cardiol (Engl Ed). 2020 Jan;73(1):43-52. doi: 10.1016/j.rec.2019.04.016. Epub 2019 Sep 12. English, Spanish.
citation: Garcia-Ortiz L, Recio-Rodriguez JI, Agudo-Conde C, Maderuelo-Fernandez JA, Patino-Alonso MC, de Cabo-Laso A, Rodriguez-Martin C, Gonzalez-Sanchez J, Rodriguez-Sanchez E, Gomez-Marcos MA; on behalf the EVA Investigators group. Noninvasive validation of central and peripheral augmentation index estimated by a novel wrist-worn tonometer. J Hypertens. 2018 Nov;36(11):2204-2214. doi: 10.1097/HJH.0000000000001806.