An interventional study of Lifestyle intervention in Cardiovascular Diseases and Atherosclerosis, sponsored by VASCage GmbH. Completed at 1 site in Austria. Open to participants aged 14 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by VASCage GmbH · Not applicable, Interventional, and Prevention
Among 53 studies in Atherosclerosis with a site in Austria — 4 open to participants now, 11 under way, 7 of them phase 3. Atherosclerosis · Austria.
Among the 53 studies in Atherosclerosis with a site in Austria, this one is the 21st largest by enrollment of the 37 interventional ones that give a count, is the only one that started in 2023, is one of 18 with no phase, and was the 47th registered.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
Browse Atherosclerosis studies →4 of the 53 studies in Atherosclerosis with a site in Austria are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Austria, United States, Argentina and 25 more countries
CSL Behring · Sites in Austria, United States, Argentina and 32 more countries
Women's Heart Austria · Sites in Austria
VASCage GmbH · Sites in Austria
A study can be open while its sites in Austria have not opened yet or have stopped. Only those recruiting at a site in Austria →
Of the 161 Atherosclerosis studies recruiting now, 84 (52%) set no upper age limit and 33 (20%) stop at 75 or younger; 16 take children under 18; 33 take healthy volunteers.
This study: 14 Years to 99 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 13 · Phase 4 5
First in 2003; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 171 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Median enrollment 299 across the 37 interventional studies, 581 across the 16 observational. Of the 36 that completed or were terminated, 13 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 53 have an industry lead sponsor. The 10 most frequent:
VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
VASCage GmbH has 3 studies filed under Atherosclerosis — fewer than ten, so there is no comparison to draw.
2 of the studies in Atherosclerosis with a site in Austria that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05030428Phase 3Novartis PharmaceuticalsStudy of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 2027-05-10 |
| NCT07780552VASCage GmbHCHIP in Health and Disease | 2027-03 |
Among the 53 studies in Atherosclerosis with a site in Austria, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this single-center prospective randomized controlled parallel 2-arm intervention study is to test a lifestyle intervention focusing on diet and physical activity in students and at least one legal guardian to improve cardiovascular risk factor profiles.
The primary objective of this study ist to evaluate the efficacy of a health promotion intervention (intervention group) over the course of a year using a participative approach compared to a control group in 14- to 17-year-olds and at least one legal guardian.
Further study objectives are to determine the effect of the health promotion intervention on the change of the score of the individual health metric components, on the absolute health metric score, on the change in intima-media thickness and pulse-wave velocity and cardiovascular health (such as blood pressure, non-HDL-cholesterol, BMI) as well as health literacy with regards to CVDs, especially stroke, in both age-groups.
Furthermore, a biobank will be collected.
YOUhealTH is a single-center prospective randomized controlled parallel 2-arm intervention study with the aim to test a lifestyle intervention focusing on diet and physical activity in students and at least one legal guardian to improve cardiovascular risk factor profiles. The lifestyle intervention is designed using a participative approach of adolescents who are part of the study team and design the intervention. This intervention is applied to students aged 14- to 17-years and at least one legal guardian for the duration of one year. At the beginning and the end of the intervention, an examination including a blood draw, a structured medical interview, anthropometrics including blood pressure measurement, ultrasonography of the aorta and the carotid artery, pulse-wave velocity and bioelectrical impedance measurement as well as FibroScan (a liver fat and elasticity measurement) is conducted and the effects of the intervention are evaluated compared to the control group receiving no intervention. Students and their legal guardians are randomized to the intervention or control group in a school-wise manner and in a 4:3 ratio.
The primary objective is to determine the effect of the health intervention with regards to the change of the health metric components diet and physical activity of the Life's Essential Eight score of the American Heart Association. Further study objectives are to evaluate the effect of the health promotion intervention on the change of the score of the individual health metric components, on the absolute health metric score, on the change in intima-media thickness and pulse-wave velocity and cardiovascular health (such as blood pressure, non-HDL-cholesterol, BMI) as well as health literacy with regards to CVDs, especially stroke, in both age-groups.
Furthermore, a long-term follow-up by means of record linkage is planned and a biobank will be collected.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's enrollment of 171 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Compared within Atherosclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lifestyle intervention with focus on increased physical activity and healthy diet.
Behavioral: Lifestyle intervention
No lifestyle intervention. No change in physical activity or diet.
Lifestyle intervention focusing on diet and physical activity
Efficacy of health promotion intervention
The efficacy of the health promotion intervention to improve cardiovascular health in 14- to 17 year-olds and at least one legal guardian measured by means of change of the "2022 cardiovascular health metrics score (0-100 points)" for the components of diet and physical activity from baseline to follow-up of the intervention group using a participative approach compared to a control-group.
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Health promotion intervention
The effect of the health promotion intervention on both the change and the absolute values of the "2022 cardiovascular health metrics score (0-100 points)" and its components in the whole study group and in adolescents and adults separately.
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Health literacy
The effect of the health intervention on health literacy (measured by means of a CVD (HELMA; score) and stroke knowledge questionnaire (%)).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Pulse-wave velocity change
The effect of the health intervention on pulse-wave velocity (m/s)
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Intima-media thickness change
The effect of the health intervention on intima-media thickness (µm).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Liver fat content change
The effect of the health intervention on liver fat content (dB/m).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Blood pressue change
The effect of the health intervention on blood pressure (mmHg).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Body-/fat composition change
The effect of the health intervention on body-/fat composition (%)
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Visceral fat thickness change
The effect of the health intervention on abdominal visceral fat thickness (mm).
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Physical activity change
The effect of the health intervention on the average minutes of moderate to vigorous physical activity per day (min/day).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. blood lipids
Risk profiles (e.g. blood lipids such as LDL-C (mg/dl)) of adolescents will be compared to their legal guardian(s).
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Risk profile - e.g. Blood sugar
Risk profiles (e.g. blood sugar (HbA1c (%)) of adolescents will be compared to their legal guardian(s).
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Healthy diet
Risk profiles (healty diet (MEPA score;%)) of adolescents will be compared to their legal guardian(s).
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Risk profile - Smoking
Risk profiles (smoking (questionnaire, score) of adolescents will be compared to their legal guardian(s).
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - hypertension
The prevalence of traditional cardiovascular risk factors such as hypertension (mmHg) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12 +/- 2 months)
Cardiovascular risk factor description - obesity
The prevalence of traditional cardiovascular risk factors such as obesity (e.g.BMI (kg/m\^2)) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - dislipidemia
The prevalence of traditional cardiovascular risk factors such as dyslipidemia (e.g. LDL-C (mg/dl)) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Cardiovascular risk factor description - diabetes
The prevalence of traditional cardiovascular risk factors such as diabetes (HbA1c (%)) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - unhealthy diet
The prevalence of lifestyle factors such as unhealthy diet (MEPA-score; %) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - sedentary lifestyle
The prevalence of lifestyle factors such as sedentary lifestyle (Physical activity component of of Life's Essential 8 assessment; %) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Lifestyle factor description - smoking
The prevalence of lifestyle factors such as smoking (YES/NO, cigarettes per day) in the Tyrolean youth and their legal guardians will be described.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
High-risk population exploration
High-risk populations (Life's essential 8 score; %) based on school type, age, sex and region of residence will be explored.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Time trends
Time trends in risk-profiles will be evaluated by comparison to the data from the "Early vascular Ageing" and the "Early Vascular Ageing in YOUth" study.
Time frame: Baseline visit until follow-up visit (at 12+/- 2 months)
Long-term Intervention - CVD events
Evaluation of predictors for later cardio- and cerebrovascular disease (events or deaths) in adolescents and their legal guardian by record linkage to electronic health record.
Time frame: Every 2-5 years, on average for the duration of 50 years
Long-term Intervention - any deaths
Evaluation of predictors for later mortality in adolescents and their legal guardian by record linkage to death registry.
Time frame: Every 2-5 years, on average for the duration of 50 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Mar 2025, 25 months.
Of 177 non-industry interventional studies with no phase under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 25 months is below that.
Counting every sponsor, half of 197 studies reached it within 30 months; a quarter within 17 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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VASCage GmbH