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

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.

Conditions

• Coronary Artery Disease

Interventions

OTHER

Exercise exposure

Exercise is NOT part of our study protocol. Participants will voluntarily participate in a mass-participation exercise event (i.e. walking, cycling or running). Participation in this exercise event is voluntary and independent from participation in this study (i.e. participants would also take part in the exercise event if they did not participate in our study). Therefore, we do not consider the performed exercise an intervention or part of our study protocol. Hence, we consider our study design to be observational. Participants will perform exercise during a mass-participation exercise event, stratified for type of exercise (walking versus running versus cycling; n=500 each). The mass-participation exercise events have a sport-specific minimum distance of: a mass-participation exercise event with a: * Walking distance ≥20 km * Cycling distance ≥100 km * Running distance ≥15 km

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Thijs Eijsvogels, PhD · Radboud University Medical Center

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-15

Primary Completion

2024-07-01

Completion

2044-07-01

Countries

• Netherlands

Study Locations