Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VASCage GmbH
- 入组人数
- 1,517
- 试验地点
- 1
- 主要终点
- Determinants of the Pulse-Wave Velocity [m/s]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents at the age of 14 to 19 years
- •Signed informed consent of subjects (and legal guardian if subject < 18 years of age)
排除标准
- •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
结局指标
主要结局
Determinants of the Pulse-Wave Velocity [m/s]
时间窗: 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.
Determinants of Intima-Media Thickness (carotid and aortic)
时间窗: 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
次要结局
- 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)