Early Vascular Ageing in the YOUth (EVA4YOU)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension; Obesity; Overweight; Sleep Disorder; Atherosclerosis; Sleep; Headache; Vascular Stiffness; Cardiovascular Risk Factor; Non-Alcoholic Fatty Liver Disease; Life Style; Cardiovascular Pathology

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 Type: Observational
• Enrollment (Actual): 1517

Contacts and Locations

• Study Contact: Name: Michael Knoflach, MD; Phone Number: +43 50 504 81697; Email: michael.knoflach@i-med.ac.at
• Study Contact Backup: Name: Ursula Kiechl-Kohlendorfer, MD; Phone Number: +43 50 504 27307; Email: ursula.kohlendorfer@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

students and apprentices aged 14-19 years

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: VASCage GmbH
• Collaborators: Medical University Innsbruck; Tirol Kiniken GmbH
• Investigators: Principal Investigator: Michael Knoflach, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Headache; Sleep; Ultrasonography; Blood Pressure; Body Mass Index; Adolescence; Vascular Stiffness; Non-Alcoholic Fatty Liver Disease; Bioimpedance; Life Style; Cardiovascular Risk Factor; Intima-Media Thickness; Cardiovascular Pathology; Early Vascular Ageing; Liver Elastography
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Body Weight; Liver Diseases; Cardiovascular Diseases; Vascular Diseases; Sleep Wake Disorders; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease; Headache; Atherosclerosis
• Other Study ID Numbers: EVA4YOU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymized data can be shared in academic cooperations. Request for data can be addressed to the principal investigators with an appropriate research question.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No