COUREUR Study Myocardial Inflammation in Cyclist Part 2
Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2
1 other identifier
interventional
19
2 countries
2
Brief Summary
The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes. Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study. Each participant will complete a detailed questionnaire detailing their training history. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max. In part 2 of the study cardiac MRI will be performed at rest before the EDT cycling ride completion. An ECG registration using a RootiRx will be realized during and up to 6 hours after the cycling ride. An echocardiography and cardiac MRI will be repeated in each cyclist between 3 and 6 hours after EDT cycling ride completion. A blood sample will be obtained at that time after the ride. This time point is chosen based on the highest troponin release that 3 to 6 hours post-exercise would allow a sufficient amount of time for inflammation to develop and be detectable, corresponding with the time when cardiac Troponin T is typically detectable and representing the liberation of enzymes from damaged myocytes. Finally, a third cardiac MRI will be repeated 24 hours after start of the cycling ride to verify the evolution of possible inflammation over this time period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedOctober 12, 2023
October 1, 2023
4 days
June 18, 2021
October 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise
T1 and T2 relaxation time will be measured on cardiac MRI in cyclists before and 3 to 6 hours after a high intense and sustained exercise to assess exercise-induced myocardial inflammation
12 months after study
Study Arms (1)
Recreational cyclists performing the 'étape du tour (EDT) de France 2021
OTHERInterventions
T1 and T2 relaxation times will be evaluated on basal and mid-cavity SA maps; a single ROI measurement in the septum will be manually drawn sufficiently far from tissue interfaces to avoid the impact of susceptibility artifacts from adjacent tissues. The differences in T1 and T2 relaxation times between rest and post-exercise will be analyzed. Cardiac ventricular volumes, function and LV mass will also be quantified.
Measurements of mass, volumes and function will be obtained of both the left and right ventricles enabling comparisons with cardiac MRI and traditional echo measures.
The final report will include the amount of recorded beats, the average heart rate, the maximum and minimum heart rate, the amount of cardiac pauses defined as an interruption in the ventricular rate \> 2 seconds. Reported atrial events include atrial ectopic beats and supraventricular tachycardia and ventricular events include ventricular ectopic beats, doublets, triplets, bigeminy, trigeminy and ventricular tachycardia.
Blood sample will be performed 3 to 6 hours after the stage to analyze high-sensitivity cardiac Troponin T (high-sensitivity) levels, Creatine Phosphokinase (CPK) to eliminate the hypothesis of Troponin elevation induced by rhabdomyolysis and C-reactive Protein to corroborate the inflammatory aspect if there is any.
Eligibility Criteria
You may qualify if:
- Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride
You may not qualify if:
- presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases, active SARS-CoV-2 infection and the intake of anti-inflammatory drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jessa Hospitallead
- Centre Hospitalier Universitaire de Nicecollaborator
Study Sites (2)
Jessa Hospital
Hasselt, 3500, Belgium
Centre Hospitalier Universitaire de Nice
Nice, France
Related Publications (1)
Ghekiere O, Herbots L, Peters B, Berg BV, Dresselaers T, Franssen W, Padovani B, Ducreux D, Ferrari E, Nchimi A, Demanez S, De Bosscher R, Willems R, Heidbuchel H, La Gerche A, Claessen G, Bogaert J, Eijnde BO. Exercise-induced myocardial T1 increase and right ventricular dysfunction in recreational cyclists: a CMR study. Eur J Appl Physiol. 2023 Oct;123(10):2107-2117. doi: 10.1007/s00421-023-05259-4. Epub 2023 Jul 22.
PMID: 37480391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
November 30, 2021
Study Start
July 1, 2021
Primary Completion
July 5, 2021
Study Completion
October 1, 2023
Last Updated
October 12, 2023
Record last verified: 2023-10