Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
- Conditions
- MyocarditisCOVID-19
- Interventions
- Diagnostic Test: Resting electrocardiogramDiagnostic Test: Stress testDiagnostic Test: Cardiac echocardiographyDiagnostic Test: Cardiac rhythm monitoringOther: QuestionnaireDevice: Injected Cardiac MRIBiological: Blood sampling for biobank
- Registration Number
- NCT04936503
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.
Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.
The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.
Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 984
- High level athlete,
- Of both sexes and age ≥ 18 years,
- Affiliated to or beneficiary of a social security system,
- Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research),
- Effective method of contraception for women with childbearing capacity.
- Minor,
- History of ventricular arrhythmia, myocarditis, identified coronary artery disease or documented myocardial fibrosis,
- Pregnant or breastfeeding women,
- Person unable to give informed consent,
- Person deprived of liberty by judicial or administrative decision,
- Adults subject to a legal protection measure (guardianship, curator, safeguard of justice).
Specific exclusion criteria for the MRI component (Contraindications):
- Subject with an implantable pacemaker or defibrillator, intraocular metallic foreign body, intracranial metallic clip, pre 6000 Starr-Edwards type cardiac valve prosthesis, or biomedical device such as insulin pump or neurostimulator,
- Hypersensitivity to gadolinium or to one of the excipients of the contrast product used,
- Claustrophobic subjects or those unable to remain in an immobile lying position for 30 minutes,
- Renal insufficiency with creatinine clearance of less than 30 ml/min,
- A patient whose shoulder width does not allow installation in the MRI machine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-level athletes Stress test High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Questionnaire High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Blood sampling for biobank High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Resting electrocardiogram High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Cardiac rhythm monitoring High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Injected Cardiac MRI High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects. High-level athletes Cardiac echocardiography High level athletes are rugby players, intervention unit agents of the National Police, sports students. Definition of a COVID-19 positive subject : Any subject whose serology is positive (IgM and/or IgG) and/or the Reverse Transcription Polymerase Chain Reaction (RT-PCR) result is positive and/or the questionnaire is positive and/or a new electrocardiogram (ECG) abnormality. The COVID-19 negative subjects do not meet the definition of COVID-19 positive subjects.
- Primary Outcome Measures
Name Time Method Presence of rhythmic risk markers bye the questionnaire Day 0 Questionnaire looking for heart palpitations, chest pain/pressure and shortness of breath.
Evaluation by resting ECG of rhythmic risk marker : repolarization disorders Day 0 Presence or absence of repolarization disorders
Evaluation by resting ECG of rhythmic risk marker : inverted T waves Day 0 Presence or absence of inverted T waves
Presence of rhythmic risk markers bye ECG holter Day 0 VES, especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex shapes (repetitive, multiple morphologies, instantaneous cycle \>200bpm), ventricular tachycardias (VTs). Ventricular arrhythmias are quantified.
Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities Day 0 Presence or absence of ST segment abnormalities
Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES) Day 0 Presence or absence of VES. Ventricular extrasystoles especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex forms (repetitive, several morphologies, instantaneous cycle \>200bpm)
Presence of rhythmic risk markers bye ECG monitoring during games and trainings Day 0 In case of moderate arrhythmia on stress test and/or Holter ECG, ECG monitoring during training sessions and matches is carried out with analysis of the tracings collected, in search of more sustained arrhythmia, particularly at the ventricular level.
Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration Day 0 If the risk is perceived as very high, pharmacological tests (Isuprel®) and/or electrophysiological exploration may be performed during hospitalization, in search of dangerous rhythm disorders, particularly at the ventricular level.
Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation Day 0 Presence or absence of QRS fragmentation
Presence of rhythmic risk markers bye the stress test Day 0 VES, especially with short coupling (\<300ms), falling on the T wave, width \> 160ms, complex shapes (repetitive, several morphologies, instantaneous cycle \>200bpm), ventricular tachycardias (VT). The analysis focus on the exercise period, and the recovery period. Ventricular arrhythmias will be quantified.
Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT) Day 0 Presence or absence of VT.
- Secondary Outcome Measures
Name Time Method Presence of myocardial fibrosis by injected MRI Month 3 In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed. The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology. The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm. The images are reviewed by a core lab at the Bordeaux University Hospital. The presence or absence of myocardial fibrosis is evaluated.
Research of inflammation markers Month 5 Th1/Th2/activation/inflammation/apoptosis markers are measured in sera by a Luminex test allowing the detection of 10 analytes with a commercial kit according to the manufacturer's instructions
Presence of transmural localization of myocardial fibrosis by injected MRI Month 3 In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed. The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology. The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm. The images are reviewed by a core lab at the Bordeaux University Hospital. The presence or absence of transmural localization is evaluated.
Measurement of cardiac scar size by injected MRI Month 3 In order to compare the prevalence of myocardial fibrosis between COVID-19 positive and COVID-19 negative individuals in high level athletes with or without rhythmic risk, a high resolution MRI is performed. The examinations is performed on 1.5 or 3T MRI systems equipped with specific antennas for cardiology. The sequence used to detect occult scars is a late enhancement sequence performed at least 15 minutes after injection of gadolinium salts, using a free-breathing 3D method, for a minimum spatial resolution of 2.5x1.25x1.25mm. The images are reviewed by a core lab at the Bordeaux University Hospital. The size of scars is measured in milliliters (mL).
Search for constitutional genetic biomarkers Month 5 identification by sequencing of genetic variants that could have an impact on the occurrence of a severe form in individuals infected with SARS-CoV-2.
Trial Locations
- Locations (21)
Stade Rochelais Rugby training center
🇫🇷La Rochelle, France
Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
🇫🇷Bordeaux, France
AS Montauban Rugby training center
🇫🇷Montauban, France
Training center Soyaux Angoulême XV Rugby
🇫🇷Angoulême, France
Training Center Stade Aurillacois
🇫🇷Aurillac, France
Aviron Bayonnais Rugby Pro Training Center
🇫🇷Bayonne, France
Biarritz Olympique Pays Basque training center
🇫🇷Biarritz, France
Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
🇫🇷Bordeaux, France
Union Bordeaux-Bègles training center
🇫🇷Bègles, France
CABCL Rugby Training Center
🇫🇷Brive-la-Gaillarde, France
US Carcassonne Rugby training center
🇫🇷Carcassonne, France
Union Sportive Colomiers Rugby training center
🇫🇷Colomiers, France
FC Grenoble Rugby training center
🇫🇷Grenoble, France
Racing92 training center
🇫🇷Le Plessis-Robinson, France
US Nevers Rugby training center
🇫🇷Nevers, France
Section Paloise Rugby training center
🇫🇷Pau, France
Stade Français training center
🇫🇷Paris, France
USAP Training Center
🇫🇷Perpignan, France
Castres Olympique training center
🇫🇷Saix, France
Stade Toulousain Rugby training center
🇫🇷Toulouse, France
Training center Valence Romans Drôme Rugby
🇫🇷Romans-sur-Isère, France