protocolSection identificationModule nctId: NCT06295081, orgStudyIdInfo id: NL79864.091.22, secondaryIdInfos id: 112927, type: OTHER, domain: RadboudUMC, briefTitle: TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance, acronym: TREAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2044-07-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: Maastricht University Medical Center, descriptionModule briefSummary: 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 concentrationsPhase 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., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Exercise exposure, outcomesModule primaryOutcomes measure: High-sensitivity cardiac troponin I (hs-cTnI), primaryOutcomes measure: High-sensitivity cardiac troponin T (hs-cTnT), secondaryOutcomes measure: General CT scan data, secondaryOutcomes measure: Coronary artery calcification score, secondaryOutcomes measure: Coronary stenosis and plaque characteristics, secondaryOutcomes measure: Computed tomography derived Fractional Flow Reserve, secondaryOutcomes measure: Incidence of mortality, secondaryOutcomes measure: Incidence of major adverse cardiovascular events, otherOutcomes measure: Participant characteristics (personal info), otherOutcomes measure: Participant characteristics (baseline measurements), otherOutcomes measure: Participant characteristics (Exercise characteristics):, otherOutcomes measure: Medical History questionnaire, part 1 (general info and cardiovascular complaints), otherOutcomes measure: Medical History questionnaire, part 2 (diseases and/or conditions), otherOutcomes measure: Medical History questionnaire, part 3 (family history, COVID-19 info and medication use), otherOutcomes measure: Exercise History questionnaire, part 1 (exercise history, participation in endurance races and current training status), otherOutcomes measure: Exercise History questionnaire, part 2 (strength exercise), otherOutcomes measure: Other biomarker concentrations in blood, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RadboudUMC, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525 GC, country: Netherlands, contacts name: Sylvan Janssen, MSc, role: CONTACT, phone: +31243613416, email: sylvan.janssen@radboudumc.nl, contacts name: IKS Integraal kwaliteitssysteem, role: CONTACT, phone: +31243614894, email: integraalkwaliteitssysteemwetenschappelijkonderzoek@radboudumc.nl, geoPoint lat: 51.8425, lon: 5.85278, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2023-01-16, uploadDate: 2023-04-13T09:57, filename: Prot_SAP_ICF_000.pdf, size: 852144, hasResults: False