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Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.
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| Name | Class |
|---|---|
| The Joel Cornette Foundation | UNKNOWN |
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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)
• Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study.
With COVID-19
• COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment
Or without COVID-19
• Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation
Participants 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.
No physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athletes with COVID-19 | |||
| Athletes without COVID-19 (control) |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) | Up to 7 months | |
| Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of abnormal ECGs as measured by medical record abstraction | Up to 7 months | |
| Number of abnormal Troponin as measured by medical record abstraction | Up to 7 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Any adult athlete, defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete, with COVID-19 compared to any adult athlete without COVID-19.
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| Name | Affiliation | Role |
|---|---|---|
| Manesh Patel, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| Number of abnormal echocardiogram as measured by medical record abstraction |
| Up to 7 months |