Clinical trial NCT04736004: Hearts of Athletes
Official title: Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Involvement With COVID-19
Keywords: athletes
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Joel Cornette Foundation
First posted: 2021-02-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult athlete, defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete, with COVID-19 compared to any adult athlete without COVID-19.

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.


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)

Primary outcomes:
measure: Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
timeFrame: Up to 7 months
measure: Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
timeFrame: Up to 7 months
Secondary outcomes:
measure: Number of abnormal ECGs as measured by medical record abstraction
timeFrame: Up to 7 months
measure: Number of abnormal Troponin as measured by medical record abstraction
timeFrame: Up to 7 months
measure: Number of abnormal echocardiogram as measured by medical record abstraction
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: