Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 11:31 PM
Study NCT ID:
NCT04736004
Status:
TERMINATED
Last Update Posted:
2025-10-02
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearts of Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)', 'timeFrame': 'Up to 7 months'}, {'measure': 'Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)', 'timeFrame': 'Up to 7 months'}], 'secondaryOutcomes': [{'measure': 'Number of abnormal ECGs as measured by medical record abstraction', 'timeFrame': 'Up to 7 months'}, {'measure': 'Number of abnormal Troponin as measured by medical record abstraction', 'timeFrame': 'Up to 7 months'}, {'measure': 'Number of abnormal echocardiogram as measured by medical record abstraction', 'timeFrame': 'Up to 7 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['athletes'], 'conditions': ['Cardiac Involvement With COVID-19']}, 'descriptionModule': {'briefSummary': 'The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)\n\n• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study.\n\nWith COVID-19\n\n• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment\n\nOr without COVID-19\n\n• Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation\n\nParticipants with and without COVID-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. Also, participants will allow their de-identified cardiac images to be sent to the Duke Heart Center for blinded analysis.\n\nNo physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any adult athlete, defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete, with COVID-19 compared to any adult athlete without COVID-19.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult athlete (defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete) will be eligible for the study.\n* COVID-19 diagnosed via an RT-PCR, or history of COVID-19 antibodies at least 10 days and less than 6 months prior to consent\n* No longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation.\n* Identification as a Control participant (similar sport) to a participant without COVID-19 willing to undergo cardiovascular evaluation\n\nExclusion Criteria:\n\n* Anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease\n* Anyone without the ability to provide informed consent\n* Anyone with a known contraindication to cardiac magnetic resonance (metallic implant)'}, 'identificationModule': {'nctId': 'NCT04736004', 'briefTitle': 'Hearts of Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19', 'orgStudyIdInfo': {'id': 'Pro00106943'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Athletes with COVID-19'}, {'label': 'Athletes without COVID-19 (control)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Manesh Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Joel Cornette Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}