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AzTrials

HealthyNCT02623894

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

An observational study of Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Healthy
How many people
500 participants
Where
2 sitesSpain
Study dates
Oct 2015to Dec 2017
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Patients aged 35 to 75 years who agree to participate in the study and do not meet any of the exclusion criteria.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Primary care Research unit. La Alamedilla health centre

    Salamanca, 37003

  • Manuel A Gómez Marcos

    Salamanca, 37006

Other trials in Spain

About this study

Official title: Influence of Different Risk Factors in Vascular Accelerated Aging. A Cross-sectional, Descriptive Observational Study (EVA Study)

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.

Read more

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other

    No intervention study is an observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardio-ankle vascular index

    This parameter will be estimated using Vasera device VS-1500.

    Measured: 2 years

Secondary outcomes (11)

  1. Brachial-ankle pulse wave velocity (ba-PWV)

    This parameter will be estimated using Vasera device VS-1500.

    Measured: 2 years

  2. Ankle-brachial index

    This parameter will be estimated using Vasera device VS-1500.

    Measured: 2 years

  3. Central augmentation index

    This parameter will be estimated using the Sphygmo Cor System.

    Measured: 2 years

  4. Carotid Intima Media Thickness

    A Sonosite Micromax ultrasound device paired with a 5-10 MHz multifrequency high-resolution linear transducer with Sonocal software.

    Measured: 2 years

  5. Evaluation of retinal vessels

    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.

    Measured: 2 years

  6. Adherence to the mediterranean diet

    Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.

    Measured: 2 years

  7. Objective measure of physical activity

    It will be measured using Actigraph GT3X accelerometers.

    Measured: 2 years

  8. Self-reported physical activity

    It will be measured using the International Physical Activity Questionnaire - Short Form.

    Measured: 2 years

  9. Sedentary time

    It will be measured using the Questionnaire hours seated (Marshall).

    Measured: 2 years

  10. Subjective assessment of physical activity

    It will be measured using the Paffenbarger Physical Activity Questionnaire.

    Measured: 2 years

  11. Carotid-femoral pulse wave velocity

    This parameter will be estimated using the Sphygmo Cor System.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623894
Sponsor's protocol ID
GRS 1193/B/15
Status last verified
Feb 2020
First submitted
23 Nov 2015
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27267107

  • Gonzalez Falcon D, Gomez-Sanchez L, Gomez-Sanchez M, Rodriguez-Sanchez E, Tamayo-Morales O, Lugones-Sanchez C, Gonzalez-Sanchez S, Diaz M, Gomez-Marcos MA; en representacion de investigadores del estudio EVA. Evolution of arterial stiffness and association with cardiovascular risk factors in the Spanish population. Follow-up EVA. Med Clin (Barc). 2025 May 9;164(9):461-469. doi: 10.1016/j.medcli.2024.11.008. Epub 2025 Jan 11. English, Spanish.

    PubMed 39800597

  • Gomez-Sanchez L, Gomez-Sanchez M, Rodriguez-Sanchez E, Lugones-Sanchez C, Tamayo-Morales O, Gonzalez-Sanchez S, de Cabo-Laso A, Garcia-Ortiz L, Gomez-Marcos MA; EVA Investigators. Association of Accelerometer-Measured Sedentary Time and Physical Activity with Arterial Stiffness and Vascular Aging in the General Spanish Population, Analyzed by Sex. Rev Cardiovasc Med. 2023 Nov 17;24(11):318. doi: 10.31083/j.rcm2411318. eCollection 2023 Nov.

    PubMed 39076448

  • 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.

    PubMed 34343142

  • 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.

    PubMed 33132098

  • 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.

    PubMed 32371801

  • 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.

    PubMed 31521574

  • 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.

    PubMed 29846328

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardio-ankle vascular index (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02623894, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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