Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 11:31 PM
Study NCT ID:
NCT04736004
Status:
TERMINATED
Last Update Posted:
2025-10-02
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearts of Athletes
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
• 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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: