Hearts of Athletes

Recruiting

• Conditions: Cardiac Involvement With COVID-19

• Registration Number: NCT04736004
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2022-11-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States