Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Primary outcome
研究概览
简要总结
The main objective of this study is to evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •Patient or patient's legal healthcare proxy consents to participation
- •Documented history of SHD
- •Undergoing (or has undergone, within 30 days) a complete echocardiogram
- •Willing to have heart recordings done with two different electronic stethoscopes
排除标准
- •Patient or proxy is unwilling/unable to give written informed consent
- •Unable to complete a complete echocardiogram, or none recent completed within the last 30 days
- •No documented history of SHD
- •Experiencing a known or suspected acute cardiac event
- •Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000)
- •Unwilling or unable to follow or complete study procedures
结局指标
主要结局
Primary outcome
时间窗: 6 months
Evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and review by an expert panel of cardiologists.
次要结局
未报告次要终点