Cardiac Involvement With COVID-19 Clinical Trial
Official title:
Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
| NCT number | NCT04736004 |
| Other study ID # | Pro00106943 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 3, 2022 |
| Est. completion date | July 31, 2024 |
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | July 31, 2024 |
| Est. primary completion date | July 31, 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 30 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | The Joel Cornette Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) | Up to 7 months | ||
| Primary | Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) | Up to 7 months | ||
| Secondary | Number of abnormal ECGs as measured by medical record abstraction | Up to 7 months | ||
| Secondary | Number of abnormal Troponin as measured by medical record abstraction | Up to 7 months | ||
| Secondary | Number of abnormal echocardiogram as measured by medical record abstraction | Up to 7 months |