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AtherosclerosisEVA4YOUNCT04598685

Early Vascular Ageing in the YOUth

An observational study of Atherosclerosis and Cardiovascular Risk Factor, run by VASCage GmbH at 1 site in Austria.

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

This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity. Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
How many people
1,517 participants
Where
1 siteAustria
Study dates
1 Feb 2021to 31 Mar 2023
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 14 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: students and apprentices aged 14-19 years

Who may be able to join

  • Adolescents at the age of 14 to 19 years
  • Signed informed consent of subjects (and legal guardian if subject < 18 years of age)

Who cannot join

  • Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).
  • Persons with impaired power of judgment
  • Persons who are currently engaged in military or community service

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Official title: Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents

This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity.

A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

Read the detailed description

EVA4YOU is a cross-sectional study enrolling 3000 students and apprentices aged between 14 and 19 years. Examinations are conducted at schools and companies throughout Tyrol, Austria and include laboratory measurements; standardized medical interviews; anthropometry; liver elastography; ultrasonography of the carotid artery and the aorta, and blood pressure, bioelectrical impedance; visceral abdominal fat-tissue-thickness measurement, pulse-wave velocity measurements.

The study hypothesis is that the cardiovascular risk factors measured already influence the formation of atherosclerosis (measured as carotid and aortic Intima-Media Thickness and Pulse-Wave-Velocity) in adolescents.

A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

Keywords
Cardiovascular Diseases, Cardiovascular Risk Factor, Atherosclerosis, Cardiovascular Pathology, Life Style, Vascular Diseases, Early Vascular Ageing, Vascular Stiffness, Intima-Media Thickness, Non-Alcoholic Fatty Liver Disease, Ultrasonography, Liver Elastography, Bioimpedance, Blood Pressure, Body Mass Index, Headache, Sleep, Adolescence
Medical subject headings
Atherosclerosis, Cardiovascular Diseases, Vascular Diseases, Non-alcoholic Fatty Liver Disease, Hypertension, Obesity, Overweight, Headache

What is being measured

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

  1. Determinants of Intima-Media Thickness (carotid and aortic)

    Predictors to be examined include: Blood Pressure, BMI/body composition, Smoking, Physical Activity, Family History, Lipid and Glucose Metabolism, NAFLD, Diet, Sex, Age used as predictors in multiple regression analysis

    Measured: Day 1

  2. Determinants of the Pulse-Wave Velocity [m/s]

    Predictors to be examined include: Blood Pressure, BMI/body composition, Smoking, Physical Activity, Family History, Lipid and Glucose Metabolism, NAFLD, Diet, Sex, Age used as predictors in multiple regression analysis

    The pulse-wave velocity [m/s] is measured by using the Vicorder, an oscillometric pulse-wave measurement device.

    Measured: Day 1

Secondary outcomes (3)

  1. Predictors of later cardio- and cerebrovascular disease (events and mortality) by record linkage

    Occurence of major adverse cardiovascular events (yes/no, time to event), assessed by means of automated detection of these events by record linkage

    Measured: every 2-5 years, on average for the duration of 50 years

  2. Prevalence of traditional cardiovascular risk and lifestyle factors and descripition of high-risk populations

    Measured: Day 1

  3. Time trends in risk profiles by comparison to data from the Early Vascular Ageing (EVA) study, NCT03929692

    Measured: 8 years

Timeline

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

  1. First posted22 Oct 2020
  2. Study start1 Feb 2021
  3. Primary completion28 Feb 2023
  4. Study completion31 Mar 2023

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
Cohort
Time perspective
Cross-sectional
Enrolment
1,517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598685
Sponsor's protocol ID
EVA4YOU
Acronym
EVA4YOU
Status last verified
May 2023
First submitted
23 Sep 2020
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.

Publications

  • Messner A, Nairz J, Kiechl SJ, Winder B, Hochmayr C, Granna J, Egger A, Griesmacher A, Geiger R, Knoflach M, Kiechl-Kohlendorfer U; Early Vascular Ageing in the YOUth (EVA4YOU) Study Group. Thresholds of fat mass index percentiles and their association with cardiovascular risk in adolescents: Results from the EVA4YOU study. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104408. doi: 10.1016/j.numecd.2025.104408. Epub 2025 Oct 8.

    PubMed 41087203

  • Messner A, Nairz J, Kiechl S, Winder B, Pechlaner R, Geiger R, Knoflach M, Kiechl-Kohlendorfer U; EVA4YOU Tyrol Study Group. Comparison of body mass index and fat mass index to classify body composition in adolescents-The EVA4YOU study. Eur J Pediatr. 2024 May;183(5):2203-2214. doi: 10.1007/s00431-024-05474-x. Epub 2024 Feb 22.

    PubMed 38386029

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Cardiovascular Risk Factor, run by VASCage GmbH at 1 site in Austria.

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 2 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

Determinants of Intima-Media Thickness (carotid and aortic) (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT04598685, which also lists 2 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 12 May 2023.

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