Early Vascular Ageing in the YOUth

NCT04598685 | Completed

• 1 other identifier: EVA4YOU
• Study Type: observational
• Target: 1,517
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Predictors of later cardio- and cerebrovascular disease (events and mortality) 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 Outcomes (9)

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

  Day 1

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

  Day 1

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

  Day 1

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

students and apprentices aged 14-19 years

You may qualify if:

• Adolescents at the age of 14 to 19 years
• Signed informed consent of subjects (and legal guardian if subject \< 18 years of age)

You may not qualify if:

• 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

Sponsors & Collaborators

• VASCage GmbH: lead
• Medical University Innsbruck: collaborator
• Tirol Kiniken GmbH: collaborator

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (2)

• Messner A, Nairz J, Kiechl SJ, Winder B, Hochmayr C, Granna J, Egger A, Griesmacher A, Geiger R, Knoflach M, Kiechl-Kohlendorfer U; Early Vascular Ageing in the YOUth (EVA4YOU) Study Group. Thresholds of fat mass index percentiles and their association with cardiovascular risk in adolescents: Results from the EVA4YOU study. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104408. doi: 10.1016/j.numecd.2025.104408. Epub 2025 Oct 8.

  PMID: 41087203 DERIVED

• Messner A, Nairz J, Kiechl S, Winder B, Pechlaner R, Geiger R, Knoflach M, Kiechl-Kohlendorfer U; EVA4YOU Tyrol Study Group. Comparison of body mass index and fat mass index to classify body composition in adolescents-The EVA4YOU study. Eur J Pediatr. 2024 May;183(5):2203-2214. doi: 10.1007/s00431-024-05474-x. Epub 2024 Feb 22.

  PMID: 38386029 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood: (lipidome, proteome) * whole blood (DNA) * Serum * Plasma * Stool (gut microbiome)

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Vascular Diseases; Non-alcoholic Fatty Liver Disease; Hypertension; Obesity; Overweight; Headache; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders

Study Officials

• Michael Knoflach, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 22, 2020
• Study Start: February 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

AU (1)