TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance - Trial NCT06295081

Timeline & Enrollment

Primary Outcome

High-sensitivity cardiac troponin I (hs-cTnI),High-sensitivity cardiac troponin T (hs-cTnT)

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.

ICD-10 Classifications