Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any adult athlete (defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete) will be eligible for the study.
- •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
- •No longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation.
- •Identification as a Control participant (similar sport) to a participant without COVID-19 willing to undergo cardiovascular evaluation
Exclusion Criteria
- •Anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease
- •Anyone without the ability to provide informed consent
- •Anyone with a known contraindication to cardiac magnetic resonance (metallic implant)
Outcomes
Primary Outcomes
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Time Frame: Up to 7 months
Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Time Frame: Up to 7 months
Secondary Outcomes
- Number of abnormal echocardiogram as measured by medical record abstraction(Up to 7 months)
- 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)