COUREUR Study Myocardial Inflammation in Cyclist Part 2

October 11, 2023 updated by: Jessa Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital
  • France
      • Nice, France
        • Centre Hospitalier Universitaire de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Recreational cyclists performing the 'étape du tour (EDT) de France 2021
Diagnostic test: cardiac MRI

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.

Diagnostic test: Echocardiography
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.
Diagnostic test: RootiRx for the ECG monitoring during the cycling ride
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.
Diagnostic test: Blood sample
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Collaborators

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

November 26, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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