TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,015
- 试验地点
- 1
- 主要终点
- High-sensitivity cardiac troponin T (hs-cTnT)
研究概览
简要总结
The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes.
The main questions it aims to answer are:
Question 1: What are the reference values for exercise-induced cardiac troponin elevations following walking, cycling and running exercise? Hypothesis 1: We hypothesize that the exercise-induced cTn release is different following walking, cycling and running exercise. Therefore, we will establish reference values for post-exercise cTn concentrations across each of these sport types.
Question 2: Is the prevalence of (subclinical) coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations? Hypothesis 2: We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations.
Question 3: What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events (MACE) and mortality during long-term follow-up? Hypothesis 3: We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up.
This study consists of three phases:
Phase 1: two or three visits to the study location for (amongst other measurements) blood draws to assess cardiac troponin concentrations
Phase 2: CT scan of the heart in 10% of participants to assess the prevalence of (subclinicial) coronary artery disease.
Phase 3: longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up.
Participants will visit our study centre two, three or four times:
Visit 1: baseline measurements including height, weight, body composition and blood pressure will be obtained and a blood sample will be drawn.
Visit 2: a blood sample will be drawn and activity data will be obtained from participants' own sports watch or bike computer.
Optional visit 3: a blood sample will be drawn. Visit 4: 10% of participants will undergo a cardiac CT scan to assess the prevalence of (subclinical) coronary artery disease.
详细描述
For a detailed description, please see the attached study protocol under 'Documents'.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study:
- •Renal transplantation in the past
- •Contrast nephropathy in the past
- •estimated glomerular filtration rate (eGFR) < 30 ml/min
- •Atrial fibrillation (heart rhythm disorder)
- •Previous allergic reaction to iodine contrast
- •Participation in other studies involving radiation
- •Not willing to be informed about potential incidental findings from the CT-scan
结局指标
主要结局
High-sensitivity cardiac troponin T (hs-cTnT)
时间窗: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
Concentrations of high-sensitivity cardiac troponin T (hs-cTnT) in plasma in ng/L
High-sensitivity cardiac troponin I (hs-cTnI)
时间窗: Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation
Concentrations of high-sensitivity cardiac troponin I (hs-cTnI) in plasma in ng/L
次要结局
- Computed tomography derived Fractional Flow Reserve(within 3 months after inclusion)
- Coronary artery calcification score(within 3 months after inclusion)
- Coronary stenosis and plaque characteristics(within 3 months after inclusion)
- General CT scan data(within 3 months after inclusion)
- Incidence of major adverse cardiovascular events(At 1/2/3/4/5/6/7/8/9/10/11/12/13/14/15/16/17/18/19/20 years after inclusion.Time-to-event: From the date of inclusion until the date of first documented major adverse cardiovascular event, assessed up to 20 years after inclusion.)
- Incidence of mortality(5 years after inclusion, 10 years after inclusion, 15 years after inclusion, 20 years after inclusion. Time-to-event: From the date of inclusion until the date of first documented date of death (from any cause), assessed up to 20 years after inclusion)