TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Exercise exposure
- Registration Number
- NCT06295081
- Lead Sponsor
- Radboud University Medical Center
- 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'.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1015
Not provided
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Walkers Exercise exposure Amateur athletes who perform a walking exercise with a minimum distance of 20 km Runners Exercise exposure Amateur athletes who perform a running exercise with a minimum distance of 15 km Cyclists Exercise exposure Amateur athletes who perform a cycling exercise with a minimum distance of 100 km
- Primary Outcome Measures
Name Time Method High-sensitivity cardiac troponin T (hs-cTnT) 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) 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 Outcome Measures
Name Time Method Computed tomography derived Fractional Flow Reserve within 3 months after inclusion CT-derived FFR per coronary artery (LM/LAD/LCX/RCA): FFR at the beginning of vessel (ratio); FFR at 1.5 mm diameter of vessel or most distal evaluable part (ratio); FFR at 20 mm distal from stenosis (ratio).
FFR signs for ischemia present \[=FFR≤0.75\] (yes/no); borderline ischemia \[=FFR 0.76-0.80\] (yes/no), non-ischemia \[=FFR \>0.80\] (yes/no).
FFR: fractional flow reserveCoronary artery calcification score within 3 months after inclusion Coronary artery calcium score \[=CACS\], per coronary artery or other (LM/LAD/LCX/RCA/RI/Aorta/Valves/Other) and total: lesion count (n); Agatston score (AU); volume (mm3); density (HU). Total CACS (AU); total volume (mm3); total density (HU); MESA percentile (%).
LM: left main; LAD: left anterior descending; LCX: left circumflex; RCA: right coronary artery; RI: ramus intermedius; AU: Agatston units; HU: Hounsfield units; MESA: Multi-Ethnic Study of Atherosclerosis.Coronary stenosis and plaque characteristics within 3 months after inclusion Coronary stenoses, per segment (1-18): maximum stenosis degree (0%/1-24%/25-49%/50-69%/70-99%/100%/non-diagnostic/vessel absent); number of calcified plaques (n); number of partially calcified plaques (n); number of non-calcified plaques (n).
Presence of myocardial bridging (yes/no); heart 'dominance' (PDA supplied by RCA/PDA supplied by LCX); room for general comments on CT scan.
In general, not per segment: stenosis involvement score (n); stenosis severity score (n); plaque burden (P0/P1/P2/P3/P4); high-risk plaque features, per type \[low attenuation plaque/positive remodelling/spotty calcification/napkin ring sign\] (yes/no); modifiers, per modifier \[non-diagnostic/having ≥high-risk plaque features/ischemia/exceptions including coronary artery dissection, anomalous origin of the coronary arteries, coronary artery (pseudo) aneurysm, vasculitis, coronary artery fistula, extrinsic coronary artery compression, arterio-venous malformation, other causes\] (yes/no); CAD-RADS 2.0 score.General CT scan data within 3 months after inclusion CT scan date (dd-mm-yyyy); average heart rate during scan (bpm); total radiation dose (mSv); beta-blockers administration (yes/no, if yes: dose (mg)); nitro-glycerine administration (yes/no, if yes: dose (mg)); image quality (good/moderate/poor); FFR series obtained (yes/no, if yes: quality(good/moderate/poor)); incidental findings.
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 MACE (yes/no), if yes: date, type of event (myocardial infarction/stroke/heart failure/revascularisation (both acute and elective)/sudden cardiac arrest), hospitalization (yes/no).
MACE: major adverse cardiovascular events.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 Incidence of mortality (yes/no), if yes: date of death (dd-mm-yyyy) and cause of death; cardiovascular death (yes/no).
Trial Locations
- Locations (1)
RadboudUMC
🇳🇱Nijmegen, Gelderland, Netherlands