Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19 (ASCCOVID19)

University Hospital of Bordeaux

Status: Completed

Conditions: COVID-19; Myocarditis

Treatments: Diagnostic Test: Cardiac echocardiography; Device: Injected Cardiac MRI; Diagnostic Test: Cardiac rhythm monitoring; Other: Questionnaire; Diagnostic Test: Resting electrocardiogram; Diagnostic Test: Stress test; Biological: Blood sampling for biobank

Study type: Interventional

Funder types: Other

Identifiers

NCT04936503

CHUBX 2020/16

Details and patient eligibility

About

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.

Enrollment: 984 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

984 participants in 1 patient group

High-level athletes

Experimental group

Description:

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.

Treatment:

Device: Injected Cardiac MRI

Biological: Blood sampling for biobank

Diagnostic Test: Resting electrocardiogram

Diagnostic Test: Cardiac rhythm monitoring

Diagnostic Test: Cardiac echocardiography

Diagnostic Test: Stress test

Other: Questionnaire