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Completed

NCT Number: NCT04871867

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

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..

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Professional soccer player
  • age over 18 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Cardiac abnormalities

    Time frame: up to ten days following COVID-19 infection

    qualitative

  2. acute myocarditis occurence

    Time frame: up to ten days following COVID-19 infection

    qualitative

  3. COVID19 lung lesions

    Time frame: up to ten days following COVID-19 infection

    qualitative

Secondary outcomes

  1. global occurrence of COVID19

    Time frame: one year since march 2020

    qualitative

Sponsors and collaborators

Lead sponsor

American Hospital of Paris

Other

Registry information

Official study title

Assessement of Cardiac and Lung Consequences of COVID-19 Infection in the Professional Soccer Players: A Prospective Observational Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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