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

NCT06295081 | Active Not Recruiting

• 2 other identifiers: NL79864.091.22112927
• Study Type: observational
• Target: 1,015
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; exercise; athlete; troponin; radiology; biomarker

Outcome Measures

Primary Outcomes (2)

• High-sensitivity cardiac troponin I (hs-cTnI)

  Concentrations of high-sensitivity cardiac troponin I (hs-cTnI) in plasma in ng/L

  Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation

• High-sensitivity cardiac troponin T (hs-cTnT)

  Concentrations of high-sensitivity cardiac troponin T (hs-cTnT) in plasma in ng/L

  Within 5 days before exercise event, within 6 hours post-exercise cessation, 24-48 hours post-exercise cessation

Secondary Outcomes (6)

• General CT scan data

  within 3 months after inclusion

• Coronary artery calcification score

  within 3 months after inclusion

• Coronary stenosis and plaque characteristics

  within 3 months after inclusion

• Computed tomography derived Fractional Flow Reserve

  within 3 months 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

Other Outcomes (9)

• Participant characteristics (personal info)

  At day of inclusion

• Participant characteristics (baseline measurements)

  At day of inclusion

• Participant characteristics (Exercise characteristics):

  Visit 2 (within 6 hours post-exercise cessation)

Study Arms (3)

Walkers

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

Other: Exercise exposure

Runners

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

Other: Exercise exposure

Cyclists

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

Other: Exercise exposure

Interventions

Exercise exposure 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; Runners; Walkers

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1500 Athletes will be recruited at mass-participation long-distance exercise events and stratified for type of sport (e.g. walking, cycling, running). Recruitment will take place via official websites/newsletters of the associated exercise events and social media channels. Our research has extensive experience performing studies in mass-participation exercise events, such as the Four Days Marches, Seven Hills Run, Eindhoven Marathon, Amsterdam Marathon, Maastricht Marathon in which we successfully included hundreds of participants. Therefore, we expect no difficulty to reach our target number of included participants.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Maastricht University Medical Center: collaborator

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38882206 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for assessment of biomarker concentrations in serum and/or plasma

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Thijs Eijsvogels, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: June 15, 2022
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2044
• Last Updated: November 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)