Hearts of Athletes

NCT ID: NCT04736004

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2025-09-24

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.

Conditions

Cardiac Involvement With COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Athletes with COVID-19

No interventions assigned to this group

Athletes without COVID-19 (control)

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Joel Cornette Foundation

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00106943

Identifier Type: -

Identifier Source: org_study_id