Cardiac and Lung Assessment of Professional Soccer Players Following COVID-19 Disease

Completed

• Conditions: Covid19

• Registration Number: NCT04871867
• Lead Sponsor: American Hospital of Paris

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-04
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Professional soccer player
• age over 18 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute myocarditis occurence	up to ten days following COVID-19 infection	qualitative
Cardiac abnormalities	up to ten days following COVID-19 infection	qualitative
COVID19 lung lesions	up to ten days following COVID-19 infection	qualitative

Secondary Outcome Measures

Name	Time	Method
global occurrence of COVID19	one year since march 2020	qualitative

Trial Locations

Locations (1)

American Hospital of Paris; 🇫🇷 Neuilly-sur-Seine, France