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

Recruiting
40 - 70 years of age
Both
Phase N/A

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Overview

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.

Description

For a detailed description, please see the attached study protocol under 'Documents'.

Eligibility

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

Study details

Coronary Artery Disease

NCT06295081

Radboud University Medical Center

8 March 2024

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