Early Vascular Ageing in the YOUth

Completed

• Conditions: Vascular Stiffness; Overweight; Cardiovascular Diseases; Sleep; Non-Alcoholic Fatty Liver Disease; Hypertension; Headache; Cardiovascular Risk Factor; Life Style; Vascular Diseases

• Registration Number: NCT04598685
• Lead Sponsor: VASCage GmbH

Brief 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.

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.

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.

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2021-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1517

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determinants of the Pulse-Wave Velocity [m/s]	Day 1	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.
Determinants of Intima-Media Thickness (carotid and aortic)	Day 1	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

Secondary Outcome Measures

Name	Time	Method
Predictors of later cardio- and cerebrovascular disease (events and mortality) by record linkage	every 2-5 years, on average for the duration of 50 years	Occurence of major adverse cardiovascular events (yes/no, time to event), assessed by means of automated detection of these events by record linkage
Prevalence of traditional cardiovascular risk and lifestyle factors and descripition of high-risk populations	Day 1
Time trends in risk profiles by comparison to data from the Early Vascular Ageing (EVA) study, NCT03929692	8 years

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria