TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Radboud University Medical Center
- Enrollment
- 1015
- Locations
- 1
- Primary Endpoint
- High-sensitivity cardiac troponin T (hs-cTnT)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
For a detailed description, please see the attached study protocol under 'Documents'.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
High-sensitivity cardiac troponin T (hs-cTnT)
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
- 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)