NCT07270692招募中不适用
Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm
研究概览
简要总结
The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.
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
- 是
入选标准
- •Adults aged 18 years and older
- •Able and willing to provide informed consent
- •Complete a clinical echocardiogram within 7 days before or after study procedures
排除标准
- •Unwilling or unable to provide informed consent
- •Patients who are hospitalized
结局指标
主要结局
Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm
时间窗: 15-16 months
The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.
次要结局
未报告次要终点
研究者
研究点 (3)
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