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NCT06295081Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1015 (actual)
First submitted
28 Feb 2024
Start date
15 Jun 2022
Primary completion date
1 Jul 2024
Lead sponsor
Radboud University Medical Center
NCT number
NCT06295081

What you commit to

  • Study type: Observational
  • Participants enrolled: 1015
  • From 15 Jun 2022 to the primary completion date, 1 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Renal transplantation in the past
  • Previous allergic reaction to iodine contrast
  • Participation in other studies involving radiation

Other illness

  • Atrial fibrillation (heart rhythm disorder)

Lab values

  • estimated glomerular filtration rate (eGFR) \< 30 ml/min

Other

  • A potential subject who meets any of the following criteria will be excluded from participation in Phase 2 of the study:
  • Contrast nephropathy in the past
  • Not willing to be informed about potential incidental findings from the CT-scan

Who the study is looking for

  • 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

Age in the registry: 40 years to 70 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Radboudumc
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.