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COUREUR Study Myocardial Inflammation in Cyclist Part 2

Primary Purpose

Myocardial Inflammation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cardiac MRI
Echocardiography
RootiRx for the ECG monitoring during the cycling ride
Blood sample
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Jessa Hospital
  • Centre Hospitalier Universitaire de Nice

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

Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise
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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2021
Last Updated
October 11, 2023
Sponsor
Jessa Hospital
Collaborators
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05138003
Brief Title
COUREUR Study Myocardial Inflammation in Cyclist Part 2
Official Title
Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 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
Collaborators
Centre Hospitalier Universitaire de Nice

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. 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.

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)
cardiac MRI
Intervention Description
T1 and T2 relaxation times will be evaluated on basal and mid-cavity SA maps; a single ROI measurement in the septum will be manually drawn sufficiently far from tissue interfaces to avoid the impact of susceptibility artifacts from adjacent tissues. The differences in T1 and T2 relaxation times between rest and post-exercise will be analyzed. Cardiac ventricular volumes, function and LV mass will also be quantified.
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 enabling comparisons with cardiac MRI and traditional echo measures.
Intervention Type
Diagnostic Test
Intervention Name(s)
RootiRx for the ECG monitoring during the cycling ride
Intervention Description
The final report will include the amount of recorded beats, the average heart rate, the maximum and minimum heart rate, the amount of cardiac pauses defined as an interruption in the ventricular rate > 2 seconds. Reported atrial events include atrial ectopic beats and supraventricular tachycardia and ventricular events include ventricular ectopic beats, doublets, triplets, bigeminy, trigeminy and ventricular tachycardia.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood sample will be performed 3 to 6 hours after the stage to analyze high-sensitivity cardiac Troponin T (high-sensitivity) levels, Creatine Phosphokinase (CPK) to eliminate the hypothesis of Troponin elevation induced by rhabdomyolysis and C-reactive Protein to corroborate the inflammatory aspect if there is any.
Primary Outcome Measure Information:
Title
Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise
Description
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
Time Frame
12 months after study

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, active SARS-CoV-2 infection and the intake of anti-inflammatory drugs.
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
Country
France

12. IPD Sharing Statement

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COUREUR Study Myocardial Inflammation in Cyclist Part 2

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