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临床试验/NCT04871867
NCT04871867已完成不适用

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

American Hospital of Paris1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
acute myocarditis occurence

研究概览

简要总结

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..

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Professional soccer player
  • age over 18 years

排除标准

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

结局指标

主要结局

acute myocarditis occurence

时间窗: up to ten days following COVID-19 infection

qualitative

Cardiac abnormalities

时间窗: up to ten days following COVID-19 infection

qualitative

COVID19 lung lesions

时间窗: up to ten days following COVID-19 infection

qualitative

次要结局

  • global occurrence of COVID19(one year since march 2020)

研究者

发起方
American Hospital of Paris
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilles BOCCARA

principal investigator

American Hospital of Paris

研究点 (1)

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