Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04871867
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2021-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac and Lung Assessment of Professional Soccer Players Following COVID-19 Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-05-01', 'studyFirstSubmitQcDate': '2021-05-01', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac abnormalities', 'timeFrame': 'up to ten days following COVID-19 infection', 'description': 'qualitative'}, {'measure': 'acute myocarditis occurence', 'timeFrame': 'up to ten days following COVID-19 infection', 'description': 'qualitative'}, {'measure': 'COVID19 lung lesions', 'timeFrame': 'up to ten days following COVID-19 infection', 'description': 'qualitative'}], 'secondaryOutcomes': [{'measure': 'global occurrence of COVID19', 'timeFrame': 'one year since march 2020', 'description': 'qualitative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'athletes', 'cardiac assessment', 'lung CT-scanner', 'COVID19 cardiopulmonary consequences'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32073353', 'type': 'BACKGROUND', 'citation': 'Fang Y, Zhang H, Xie J, Lin M, Ying L, Pang P, Ji W. Sensitivity of Chest CT for COVID-19: Comparison to RT-PCR. Radiology. 2020 Aug;296(2):E115-E117. doi: 10.1148/radiol.2020200432. Epub 2020 Feb 19. No abstract available.'}, {'pmid': '32250193', 'type': 'BACKGROUND', 'citation': 'Toresdahl BG, Asif IM. Coronavirus Disease 2019 (COVID-19): Considerations for the Competitive Athlete. Sports Health. 2020 May/Jun;12(3):221-224. doi: 10.1177/1941738120918876. Epub 2020 Apr 6. No abstract available.'}, {'pmid': '32508388', 'type': 'BACKGROUND', 'citation': "Eirale C, Bisciotti G, Corsini A, Baudot C, Saillant G, Chalabi H. Medical recommendations for home-confined footballers' training during the COVID-19 pandemic: from evidence to practical application. Biol Sport. 2020 Jun;37(2):203-207. doi: 10.5114/biolsport.2020.94348. Epub 2020 Apr 10."}, {'pmid': '32432700', 'type': 'BACKGROUND', 'citation': 'Schellhorn P, Klingel K, Burgstahler C. Return to sports after COVID-19 infection. Eur Heart J. 2020 Dec 7;41(46):4382-4384. doi: 10.1093/eurheartj/ehaa448. No abstract available.'}, {'pmid': '32270559', 'type': 'BACKGROUND', 'citation': 'Kochi AN, Tagliari AP, Forleo GB, Fassini GM, Tondo C. Cardiac and arrhythmic complications in patients with COVID-19. J Cardiovasc Electrophysiol. 2020 May;31(5):1003-1008. doi: 10.1111/jce.14479. Epub 2020 Apr 13.'}, {'pmid': '32387246', 'type': 'BACKGROUND', '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.'}, {'pmid': '33443538', 'type': 'BACKGROUND', '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.'}, {'pmid': '33662103', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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..', 'detailedDescription': '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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Professional soccer player\n* age over 18 years\n\nExclusion Criteria:\n\n* recent muscle injury (\\< 1 month)\n* recent orthopedic surgery (\\< 3 months)'}, 'identificationModule': {'nctId': 'NCT04871867', 'briefTitle': 'Cardiac and Lung Assessment of Professional Soccer Players Following COVID-19 Disease', 'organization': {'class': 'OTHER', 'fullName': 'American Hospital of Paris'}, 'officialTitle': 'Assessement of Cardiac and Lung Consequences of COVID-19 Infection in the Professional Soccer Players: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'americanHparis'}}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'American Hospital of Paris', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}], 'overallOfficials': [{'name': 'Gilles BOCCARA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sport and Health unit of American Hospital of Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Hospital of Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Gilles BOCCARA', 'investigatorAffiliation': 'American Hospital of Paris'}}}}