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Hearts of Athletes

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04736004
Collaborator
The Joel Cornette Foundation (Other)
500
Enrollment
1
Location
5
Anticipated Duration (Months)
100.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Athletes with COVID-19
    Athletes without COVID-19 (control)

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) [Up to 7 months]

    2. Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) [Up to 7 months]

    Secondary Outcome Measures

    1. Number of abnormal ECGs as measured by medical record abstraction [Up to 7 months]

    2. Number of abnormal Troponin as measured by medical record abstraction [Up to 7 months]

    3. Number of abnormal echocardiogram as measured by medical record abstraction [Up to 7 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • The Joel Cornette Foundation

    Investigators

    • Principal Investigator: Manesh Patel, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04736004
    Other Study ID Numbers:
    • Pro00106943
    First Posted:
    Feb 3, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duke University
    athletes
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 28, 2022