COUREUR Study Myocardial Inflammation in Cyclist Part 1
Primary Purpose
Myocardial Inflammation
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
exercise testing
Echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Inflammation
Eligibility Criteria
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 and the intake of anti-inflammatory drugs.
Sites / Locations
- Hasselt University
- Jessa Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Recreational cyclists performing the 'étape du tour (EDT) de France 2021
Arm Description
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04940650
Brief Title
COUREUR Study Myocardial Inflammation in Cyclist Part 1
Official Title
Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
October 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Inflammation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recreational cyclists performing the 'étape du tour (EDT) de France 2021
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
exercise testing
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Description
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.
Time Frame
approximately 1 week before the strenuous exercise
Title
DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
Description
Assessments of weight (in kilograms) and heigth (in meters) to determine VO2 max (ml/kg/min)
Time Frame
approximately 1 week before the strenuous exercise
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 and the intake of anti-inflammatory drugs.
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
COUREUR Study Myocardial Inflammation in Cyclist Part 1
We'll reach out to this number within 24 hrs