COUREUR Study Myocardial Inflammation in Cyclist Part 1

Sponsor

Jessa Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04940650

Collaborator

(none)

Enrollment

Locations

Arm

10.5

Anticipated Duration (Months)

9.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Inflammation	Diagnostic Test: exercise testing Diagnostic Test: Echocardiography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 16, 2021

Actual Primary Completion Date :

Jul 5, 2021

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Recreational cyclists performing the 'étape du tour (EDT) de France 2021	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. Diagnostic Test: 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.

Arm

Intervention/Treatment

Other: Recreational cyclists performing the 'étape du tour (EDT) de France 2021

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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1 [approximately 1 week before the strenuous exercise]
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 [approximately 1 week before the strenuous exercise]
Assessments of weight (in kilograms) and heigth (in meters) to determine VO2 max (ml/kg/min)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasselt University	Hasselt		Belgium	3500
2	Jessa Hospital	Hasselt		Belgium	3500

Sponsors and Collaborators

Jessa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessa Hospital

ClinicalTrials.gov Identifier:

NCT04940650

Other Study ID Numbers:

2021/020

First Posted:

Jun 25, 2021

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocarditis

Inflammation

Study Results

No Results Posted as of Apr 6, 2022