A Deep-learning-based Multi-modal Phonocardiogram(PCG) and Electrocardiogram(ECG) Processing Framework for Screening Depressed Left Ventricular Ejection Fraction (dLVEF) Using a Wearable Cardiac Patch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- Determination of Heart Failure Disease
研究概览
简要总结
The diagnosis of depressed left ventricular ejection fraction (dLVEF) (EF<50%) depends on golden standard ultrasound cardiography (UCG). A wearable synchronized phonocardiography (PCG) and electrocardiogram (ECG) device can assist in the diagnosis of dLVEF, which can both expedite access to life-saving therapies and reduce the need for costly testing.
详细描述
The synchronized PCG and ECG is wirelessly paired with the WenXin Mobile application, allowing for simultaneous recording and visualization of PCG and ECG. These features uniquely enable this device to accumulate large sets of acoustic data on patients both with and without heart failure(HF).
This study is a Case-control study. In this study, the investigators seek to develop an artificial intelligence (AI) analysis system to identify dLVEF (EF<50%) by PCG and ECG. All adults (aged ≥18 years) planned for UCG were eligible to participate (inpatients and outpatients). Specifically, the investigators will attempt to develop machine learning algorithms to learn synchronized PCG and ECG of patients with dLVEF. Then we use these algorithms to identify dLVEF subjects. The investigators anticipate to demonstrate the wearable cardiac patch with synchronized PCG and ECG can reliably and accurately diagnose dLVEF in the primary care setting.
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 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attendance at RuiJin hospital for UCG
- •Signed dated informed consent
- •Commit to follow the research procedures and cooperate in the implementation of the whole process research
- •UCG has been completed
- •At least 8 consecutive cycles of sinus rhythm can be recorded
排除标准
- •Patients with pacemakers
- •Complete left bundle branch block or block or QRS wave widening>120ms
- •Left chest skin damaged or allergic to patch
- •Refusal to participate
结局指标
主要结局
Determination of Heart Failure Disease
时间窗: one time assessment at baseline (approx. 5 minutes)
Heart Failure Disease was determined by EMAT (millisecond, ms)calculate from synchronized PCG and ECG signals using an artificial intelligence (AI) guided model.
次要结局
未报告次要终点
研究者
RUIYAN ZHANG
Director of Cardiology Department, Chief Physician
Ruijin Hospital
