COUREUR Study Myocardial Inflammation in Cyclist Part 2

Not Applicable

Completed

• Conditions: Myocardial Inflammation
• Interventions: Diagnostic Test: cardiac MRI; Diagnostic Test: Echocardiography; Diagnostic Test: RootiRx for the ECG monitoring during the cycling ride; Diagnostic Test: Blood sample

• Registration Number: NCT05138003
• Lead Sponsor: Jessa Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-18
• Study Start: 2021-07-01
• Primary Completion: 2021-07-05
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-11-30
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

• Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recreational cyclists performing the 'étape du tour (EDT) de France 2021	cardiac MRI	-
Recreational cyclists performing the 'étape du tour (EDT) de France 2021	Blood sample	-
Recreational cyclists performing the 'étape du tour (EDT) de France 2021	RootiRx for the ECG monitoring during the cycling ride	-
Recreational cyclists performing the 'étape du tour (EDT) de France 2021	Echocardiography	-

Primary Outcome Measures

Name	Time	Method
Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise	12 months after study	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

Trial Locations

Locations (2)

Jessa Hospital; 🇧🇪 Hasselt, Belgium

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France