COUREUR Study Myocardial Inflammation in Cyclist Part 1

Myocardial Inflammation Clinical Trial

Official title:

Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940650
• Other study ID #: 2021/020
• Status: Completed
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 1, 2023
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Myocardial Inflammation
• Myocarditis

Intervention

Diagnostic Test:
• exercise testing
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.
• Echocardiography
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.

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt
Belgium	Jessa Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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