Clinical trial NCT04936503: Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
Official title: Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Myocarditis
Keywords: myocardial scars
MRI
Ventricular arrhythmia
Sudden cardiac death
High-level athletes
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 984
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Presence of rhythmic risk markers bye the questionnaire
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : repolarization disorders
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : inverted T waves
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : ST segment abnormalities
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : QRS fragmentation
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : ventricular extrasystoles (VES)
timeFrame: Day 0
measure: Evaluation by resting ECG of rhythmic risk marker : ventricular tachycardia (VT)
timeFrame: Day 0
measure: Presence of rhythmic risk markers bye the stress test
timeFrame: Day 0
measure: Presence of rhythmic risk markers bye ECG holter
timeFrame: Day 0
measure: Presence of rhythmic risk markers bye ECG monitoring during games and trainings
timeFrame: Day 0
measure: Presence of rhythmic risk markers by pharmacological tests and/or electrophysiological exploration
timeFrame: Day 0
Secondary outcomes:
measure: Presence of myocardial fibrosis by injected MRI
timeFrame: Month 3
measure: Presence of transmural localization of myocardial fibrosis by injected MRI
timeFrame: Month 3
measure: Measurement of cardiac scar size by injected MRI
timeFrame: Month 3
measure: Search for constitutional genetic biomarkers
timeFrame: Month 5
measure: Research of inflammation markers
timeFrame: Month 5
Other outcomes:
Locations:
city: Angoulême
country: France
facility: Training center Soyaux Angoulême XV Rugby
city: Aurillac
country: France
facility: Training Center Stade Aurillacois
city: Bayonne
country: France
facility: Aviron Bayonnais Rugby Pro Training Center
city: Biarritz
country: France
facility: Biarritz Olympique Pays Basque training center
city: Bordeaux
country: France
facility: Bordeaux University Hospital - CRB medical office - Hôpital du Tondu
city: Bordeaux
country: France
facility: Bordeaux University Hospital - Service UDH - Hôpital Pellegrin
city: Brive-la-Gaillarde
country: France
facility: CABCL Rugby Training Center
city: Bègles
country: France
facility: Union Bordeaux-Bègles training center
city: Carcassonne
country: France
facility: US Carcassonne Rugby training center
city: Colomiers
country: France
facility: Union Sportive Colomiers Rugby training center
city: Grenoble
country: France
facility: FC Grenoble Rugby training center
city: La Rochelle
country: France
facility: Stade Rochelais Rugby training center
city: Le Plessis-Robinson
country: France
facility: Racing92 training center
city: Montauban
country: France
facility: AS Montauban Rugby training center
city: Nevers
country: France
facility: US Nevers Rugby training center
city: Paris
country: France
facility: Stade Français training center
city: Pau
country: France
facility: Section Paloise Rugby training center
city: Perpignan
country: France
facility: USAP Training Center
city: Romans-sur-Isère
country: France
facility: Training center Valence Romans Drôme Rugby
city: Saix
country: France
facility: Castres Olympique training center
city: Toulouse
country: France
facility: Stade Toulousain Rugby training center
Study officials:
affiliation: University Hospital, Bordeaux
name: Antoine Bénard, MD
role: STUDY_CHAIR
affiliation: Medical Center of the Bordeaux-Mérignac Sports Clinic
name: Laurent Chevalier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chevalier L, Cochet H, Mahida S, S SB, Benard A, Cariou T, Sridi-Cheniti S, Benhenda S, Doutreleau S, Cade S, Guerard S, Guy JM, Trimoulet P, Picard S, Dusfour B, Pouzet A, Roseng S, Franchi M, Jais P, Pellegrin I; ASCCOVID Investigators. Resuming Training in High-Level Athletes After Mild COVID-19 Infection: A Multicenter Prospective Study (ASCCOVID-19). Sports Med Open. 2022 Jun 25;8(1):83. doi: 10.1186/s40798-022-00469-0.