Clinical trial NCT04871867: Cardiac and Lung Assessment of Professional Soccer Players Following COVID-19 Disease
Official title: Assessement of Cardiac and Lung Consequences of COVID-19 Infection in the Professional Soccer Players: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID19
athletes
cardiac assessment
lung CT-scanner
COVID19 cardiopulmonary consequences
Lead sponsor: American Hospital of Paris
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since 2020 spring and during this COVID-19 outbreak, the Professional soccer player were assessed about the COVID-19 infection using the clinical tests, swab PCR Test and SARS-Cov2 serology. The athletes having COVID-19 infection were included in cardiac and lung evaluation.

Brief summary: During this world COVID-19 outbreak, and according to the experience of team doctors, after their return, some players could have been affected by the SARS-cov2. Also, this study aims to clearly determine the condition of athletes at the end of lockdown after this COVID-19 crisis and the cardiorespiratory consequences in particular in those who have been affected by COVID-19 and the prevalence of acute myocarditis. The investigators assess in this observational study the cardiac and lung consequences of COVID-19..

Detailed description: The global health crisis caused by the COVID-19 virus, beginning in November 2019, initially in China, has being marked by a rapid spread, numerous severe respiratory cases and an elevated mortality rate. Although that 85% on average of patients with SARS-cov2 are not symptomatic or poor symptoms, these people were not systematically tested by PCR and spontaneously recovered. However, at the end of lockdown, the challenge for the medical staff in each first league soccer team involves to assess their clinical health conditions including clinical evaluation, COVID-19 tests, chest CT, and cardiac function in order to detect potential anomalies. Especially, physicians should be cautious about the risk of acute viral myocarditis, often asymptomatic, in patients having COVID-19 with any or poor symptoms, reported in 7 to 28%. The risk could be a myocardial dysfunction, arrhythmic complications and/or sudden death during return to exercice.

In this observational study, the investigators included the soccer player after the spring lockdown. After firstly an exhaustive interview to assess the lockdown quality of the athlete, clinical status and potential mild or poor symptoms of COVID-19 during the outbreak, and secondly COVID-19 serology and regular PCR tests.

The athletes having a positive nasopharyngeal SARS-cov2 PCR and/or positive COVID-19 serology test, with or without symptoms, were included in the study. Up to 10 days after first positive PCR, a cardiac evaluation is done including EKG, cardiac ultrasound echography and stress test in running ground and Chest Computer Tomography (chest-CT). According to the results of cardiac tests and Lung CT-scan, these athletes also require Cardiac MRI to eliminate the risk of acute myocarditis.

Eligibility criteria: Inclusion Criteria:

* Professional soccer player
* age over 18 years

Exclusion Criteria:

* recent muscle injury (\< 1 month)
* recent orthopedic surgery (\< 3 months)

Primary outcomes:
measure: Cardiac abnormalities
timeFrame: up to ten days following COVID-19 infection
measure: acute myocarditis occurence
timeFrame: up to ten days following COVID-19 infection
measure: COVID19 lung lesions
timeFrame: up to ten days following COVID-19 infection
Secondary outcomes:
measure: global occurrence of COVID19
timeFrame: one year since march 2020
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
Study officials:
affiliation: Sport and Health unit of American Hospital of Paris
name: Gilles BOCCARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Siripanthong B, Nazarian S, Muser D, Deo R, Santangeli P, Khanji MY, Cooper LT Jr, Chahal CAA. Recognizing COVID-19-related myocarditis: The possible pathophysiology and proposed guideline for diagnosis and management. Heart Rhythm. 2020 Sep;17(9):1463-1471. doi: 10.1016/j.hrthm.2020.05.001. Epub 2020 May 5.
citation: Kim JH. Screening Athletes for Myocarditis With Cardiac Magnetic Resonance Imaging After COVID-19 Infection-Lessons From an English Philosopher. JAMA Cardiol. 2021 Aug 1;6(8):950-951. doi: 10.1001/jamacardio.2020.7463. No abstract available.
citation: Martinez MW, Tucker AM, Bloom OJ, Green G, DiFiori JP, Solomon G, Phelan D, Kim JH, Meeuwisse W, Sills AK, Rowe D, Bogoch II, Smith PT, Baggish AL, Putukian M, Engel DJ. Prevalence of Inflammatory Heart Disease Among Professional Athletes With Prior COVID-19 Infection Who Received Systematic Return-to-Play Cardiac Screening. JAMA Cardiol. 2021 Jul 1;6(7):745-752. doi: 10.1001/jamacardio.2021.0565.