COUREUR Study Myocardial Inflammation in Cyclist Part 1
Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1
1 other identifier
interventional
19
1 country
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. In part 1 of the study, each participant will complete a detailed questionnaire detailing their training history and an echocardiography at rest will be performed. 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.
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 Jun 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
Study Start
First participant enrolled
June 16, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedOctober 12, 2023
October 1, 2023
19 days
June 18, 2021
October 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Aerobic and anaerobic gas exchange heart rate thresholds, and VO2max (ml/kg/min) will be measured in all cyclists approximately 1 week before the high intense exercise. This exercise testing will be performed to evaluate high-intensity exercise as factor of exercise-induced myocardial inflammation in cyclists.
approximately 1 week before the strenuous exercise
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Assessments of weight (in kilograms) and heigth (in meters) to determine VO2 max (ml/kg/min)
approximately 1 week before the strenuous exercise
Study Arms (1)
Recreational cyclists performing the 'étape du tour (EDT) de France 2021
OTHERInterventions
To define the strenuous physical exercise in this study, each participant will be asked to perform two hours of high intensity (HIT)-effort during the endurance exercise of at least 6 to 7 hours. Therefore all participants will have exercise testing approximately 1 week before the physical exercise to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.
Measurements of mass, volumes and function will be obtained of both the left and right ventricles at rest enabling comparisons with cardiac MRI and traditional echo measures.
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 and the intake of anti-inflammatory drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jessa Hospitallead
Study Sites (2)
Hasselt University
Hasselt, 3500, Belgium
Jessa Hospital
Hasselt, 3500, Belgium
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
June 25, 2021
Study Start
June 16, 2021
Primary Completion
July 5, 2021
Study Completion
October 1, 2023
Last Updated
October 12, 2023
Record last verified: 2023-10