Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
时间窗: Up to 7 months
Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
时间窗: Up to 7 months
次要结局
- 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)