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Completed

NCT Number: NCT04598685

Early Vascular Ageing in the YOUth

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Body Weight Cardiovascular Diseases Cardiovascular Pathology Cardiovascular Risk Factor Digestive System Diseases Fatty Liver Headache Hypertension Life Style Liver Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Sleep Disorder Sleep Wake Disorders Vascular Diseases Vascular Stiffness

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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

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

    Time frame: Day 1

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

    Time frame: 8 years

Other outcomes

  1. The effect of primary headache disorders on Intima-Media Thickness [µm]

    Time frame: Day 1

    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.

  2. The effect of primary headache disorders on Pulse-Wave Velocity [m/s]

    Time frame: Day 1

    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.

  3. The effect of the gut microbiome on the cardiovascular risk profile.

    Time frame: Day 1

    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).

  4. The effect of the gut microbiome on Intima-Media Thickness [µm]

    Time frame: Day 1

    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).

  5. The effect of prenatal and infant development (early life risk factors) on Intima-Media Thickness [µm].

    Time frame: Day 1

    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.

  6. The effect of prenatal and infant development (early life risk factors) on the cardiovascular risk profile.

    Time frame: Day 1

    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.

  7. Prevalence of headache disorders (especially primary headache disorders) in adolescents

    Time frame: Day 1

    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.

  8. Risk factors for primary headache disorders in adolescents

    Time frame: Day 1

    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.

  9. Risk factors for the chronification of primary headache-disorders

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

VASCage GmbH

Other

Collaborators

  • Medical University Innsbruck
  • Tirol Kiniken GmbH

Registry information

Official study title

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

Acronym: EVA4YOU

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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