Clinical trial NCT04598685: Early Vascular Ageing in the YOUth
Official title: Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: 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
Lead sponsor: VASCage GmbH
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Tirol Kiniken GmbH
First posted: 2020-10-22
Enrollment: 1517
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: students and apprentices aged 14-19 years

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.

Eligibility 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

Primary outcomes:
measure: Determinants of Intima-Media Thickness (carotid and aortic)
timeFrame: Day 1
measure: Determinants of the Pulse-Wave Velocity [m/s]
timeFrame: Day 1
Secondary outcomes:
measure: Predictors of later cardio- and cerebrovascular disease (events and mortality) by record linkage
timeFrame: every 2-5 years, on average for the duration of 50 years
measure: Prevalence of traditional cardiovascular risk and lifestyle factors and descripition of high-risk populations
timeFrame: Day 1
measure: Time trends in risk profiles by comparison to data from the Early Vascular Ageing (EVA) study, NCT03929692
timeFrame: 8 years
Other outcomes:
measure: The effect of primary headache disorders on Intima-Media Thickness [µm]
timeFrame: Day 1
measure: The effect of primary headache disorders on Pulse-Wave Velocity [m/s]
timeFrame: Day 1
measure: The effect of the gut microbiome on the cardiovascular risk profile.
timeFrame: Day 1
measure: The effect of the gut microbiome on Intima-Media Thickness [µm]
timeFrame: Day 1
measure: The effect of prenatal and infant development (early life risk factors) on Intima-Media Thickness [µm].
timeFrame: Day 1
measure: The effect of prenatal and infant development (early life risk factors) on the cardiovascular risk profile.
timeFrame: Day 1
measure: Prevalence of headache disorders (especially primary headache disorders) in adolescents
timeFrame: Day 1
measure: Risk factors for primary headache disorders in adolescents
timeFrame: Day 1
measure: Risk factors for the chronification of primary headache-disorders
timeFrame: Day 1
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Michael Knoflach, MD
role: PRINCIPAL_INVESTIGATOR
References: