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Early Vascular Ageing in the YOUth (EVA4YOU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598685
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Medical University Innsbruck
Tirol Kiniken GmbH
Information provided by (Responsible Party):
VASCage GmbH

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Atherosclerosis Cardiovascular Risk Factor Cardiovascular Diseases Cardiovascular Pathology Life Style Vascular Diseases Vascular Stiffness Non-Alcoholic Fatty Liver Disease Hypertension Obesity Overweight Headache Sleep Sleep Disorder

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 Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Biospecimen Retention:   Samples With DNA

  • Blood: (lipidome, proteome)

    • whole blood (DNA)
    • Serum
    • Plasma
  • Stool (gut microbiome)

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
3000 students and apprentices aged 14-19 years
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598685


Contacts
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Contact: Michael Knoflach, MD +43 50 504 81697 michael.knoflach@i-med.ac.at
Contact: Ursula Kiechl-Kohlendorfer, MD +43 50 504 27307 ursula.kohlendorfer@i-med.ac.at

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Michael Knoflach, MD    +43 50 504 81697    michael.knoflach@i-med.ac.at   
Principal Investigator: Michael Knoflach, MD         
Principal Investigator: Ursula Kiechl-Kohlendorfer, MD         
Sponsors and Collaborators
VASCage GmbH
Medical University Innsbruck
Tirol Kiniken GmbH
Investigators
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Principal Investigator: Michael Knoflach, MD Medical University Innsbruck
More Information
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Responsible Party: VASCage GmbH
ClinicalTrials.gov Identifier: NCT04598685    
Other Study ID Numbers: EVA4YOU
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VASCage GmbH:
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
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Sleep Wake Disorders
Cardiovascular Diseases
Atherosclerosis
Vascular Diseases
Overweight
Headache
 Body Weight
Digestive System Diseases
Pain
Neurologic Manifestations
Arteriosclerosis
Arterial Occlusive Diseases
Nervous System Diseases
Mental Disorders