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

NCT ID: NCT06295081

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1015 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2044-07-01

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'.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Walkers

Amateur athletes who perform a walking exercise with a minimum distance of 20 km

Exercise exposure

Intervention Type: OTHER

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

Runners

Amateur athletes who perform a running exercise with a minimum distance of 15 km

Exercise exposure

Intervention Type: OTHER

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

Cyclists

Amateur athletes who perform a cycling exercise with a minimum distance of 100 km

Exercise exposure

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Participant of an affiliated mass-participation exercise event with a:

• Walking distance ≥20 km
• Cycling distance ≥100 km
• Running distance ≥15 km
• Age: ≥ 40 and <70 years old
• Able to understand and perform study related procedures

For Phase 2 of the study (i.e. assessment of (sub)clinical coronary artery disease), the following additional criteria are present:

• Free from (known) cardiovascular diseases

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thijs Eijsvogels, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

RadboudUMC

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

Janssen SLJE, Lamers SK, Vroemen WHM, Denessen EJS, Berge K, Bekers O, Hopman MTE, Brink M, Habets J, Nijveldt R, Van Everdingen WM, Aengevaeren VL, Mingels AMA, Eijsvogels TMH. Cardiac troponin concentrations following exercise and the association with cardiovascular disease and outcomes: rationale and design of the prospective TREAT cohort study. BMJ Open Sport Exerc Med. 2024 Jun 13;10(2):e002070. doi: 10.1136/bmjsem-2024-002070. eCollection 2024.

Reference Type: DERIVED

PMID: 38882206 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

112927

Identifier Type: OTHER

Identifier Source: secondary_id

NL79864.091.22

Identifier Type: -

Identifier Source: org_study_id