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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598685
Other study ID # EVA4YOU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date March 31, 2023

Study information

Verified date May 2023
Source VASCage GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1517
Est. completion date March 31, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 19 Years
Eligibility 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


Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol

Sponsors (3)

Lead Sponsor Collaborator
VASCage GmbH Medical University Innsbruck, Tirol Kiniken GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other The effect of primary headache disorders on Intima-Media Thickness [µm] Primary Headache Disorders are assessed by means of structured medical questionnaires in a physician-guided interview and classified according to the ICHD-3 Classification System. Differences in terms of vessel wall thickness [µm], measured ultrasonographically, are compared across the different primary headache diagnoses. Day 1
Other The effect of primary headache disorders on Pulse-Wave Velocity [m/s] Primary Headache Disorders are assessed by means of structured medical questionnaires in a physician-guided interview and classified according to the ICHD-3 Classification System. Differences in terms of pulse-wave velocity [m/s], measured with use of an oscillometric pulse-wave measurement device, are compared across the different primary headache diagnoses. Day 1
Other The effect of the gut microbiome on the cardiovascular risk profile. Structure and composition of the Microbiom using 16S metagenomics and shotgun metagenomics and are evaluate for their interrelationship with cardiovascular risk parameters (such as hypertension, smoking, dyslipidemia, impaired glucose tolerance, overweight/obesity, sedentary lifestyle, unhealthy dietary habits, ...).
Where appropriate additional functional insight will be obtained by metabolomics (gas chromatography and MR chromatography).
Day 1
Other The effect of the gut microbiome on Intima-Media Thickness [µm] Structure and composition of the Microbiom using 16S metagenomics and shotgun metagenomics and are assessed using stool samples and are evaluate for their influence on intima-media thickness, measured via ultrasonography. Where appropriate additional functional insight will be obtained by metabolomics (gas chromatography and MR chromatography). Day 1
Other The effect of prenatal and infant development (early life risk factors) on Intima-Media Thickness [µm]. Prenatal and infant development is assessed using records from mother-child-booklets and a questionnaire for the mother and the influence on intima-media thickness, measured using ultrasonography, is evaluated. Day 1
Other The effect of prenatal and infant development (early life risk factors) on the cardiovascular risk profile. Prenatal and infant development is assessed using records from mother-child-booklets and a questionnaire for the mother and the influence on the cardiovascular risk profile (i.e. existence of cardiovascular risk factors such as hypertension, smoking, dyslipidemia, impaired glucose tolerance, overweight/obesity, sedentary lifestyle, unhealthy dietary habits, ...) is evaluated. Day 1
Other Prevalence of headache disorders (especially primary headache disorders) in adolescents Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System. Day 1
Other Risk factors for primary headache disorders in adolescents Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System.
Risk factors to be assessed for their association with primary headache disorders include: Alcohol, caffeine and nicotine consumption, physical activity, obesity, dysfunctional familial situation, mental comorbidities are assessed in structured physician-guided interviews and questionnaires.
Day 1
Other Risk factors for the chronification of primary headache-disorders Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System.
Risk factors to be assessed for their effect on chronification of primary headache disorders include: Alcohol, caffeine and nicotine consumption, physical activity, obesity, dysfunctional familial situation, mental comorbidities are assessed in structured physician-guided interviews and questionnaires.
Day 1
Primary 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 Day 1
Primary 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.
Day 1
Secondary 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 every 2-5 years, on average for the duration of 50 years
Secondary Prevalence of traditional cardiovascular risk and lifestyle factors and descripition of high-risk populations Day 1
Secondary Time trends in risk profiles by comparison to data from the Early Vascular Ageing (EVA) study, NCT03929692 8 years
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