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Clinical Trials/NCT05138003
NCT05138003CompletedNot Applicable

Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2

Jessa Hospital2 sites in 2 countries19 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
19
Locations
2
Primary Endpoint
Myocardial inflammation will be evaluated by T1/T2 mapping cardiac MRI in cyclists after a strenuous exercise

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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, active SARS-CoV-2 infection and the intake of anti-inflammatory drugs.

Arms & Interventions

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

Other

Intervention: cardiac MRI (Diagnostic Test)

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

Other

Intervention: Echocardiography (Diagnostic Test)

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

Other

Intervention: RootiRx for the ECG monitoring during the cycling ride (Diagnostic Test)

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

Other

Intervention: Blood sample (Diagnostic Test)

Outcomes

Primary Outcomes

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

Time Frame: 12 months after study

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jessa Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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