Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Accuracy of valvular heart disease diagnosis using portable electronic stethoscope and machine learning-based diagnostic algorithms.
研究概览
简要总结
The goal of this observational study is to evaluate accuracy of portable electronic stethoscope and machine learning-based diagnostic algorithms for detecting the disease in people with valvular heart disease and healthy controls. The main question it aims to answer is:
Is portable electronic stethoscope and machine learning-based diagnostic algorithms allow accurate detection of valvular heart disease?
Researchers will compare diagnostic algorithm's predictions with the clinicians' predictions to see if the diagnostic results are accurate.
Participants will
- take echocardiogram
- take electrocardiogram using BPM Core
- get the heart auscultation data measured via electronic stethoscope
详细描述
The study compares the diagnostic accuracy of machine learning-based algorithms for diagnosis, which utilise auscultation data obtained through electronic stethoscopes, with the diagnoses made by clinicians using the same data. Two portable electronic stethoscopes used will be evaluated in this study, including BPM Core (Withings, France) and BeamO (Withings, France). The study utilises data collected from 100 patients at Queen Mary Hospital who have been diagnosed with valvular heart diseases (including aortic stenosis, mitral and/or tricuspid regurgitation, and mitral stenosis) and 25 healthy individuals without heart conditions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily agrees to participate by proving written informed consent
- •Have echocardiography done within 5 years
排除标准
- •Mechanical heart valve
- •Adult congenital heart disease
研究组 & 干预措施
Aortic stenosis
干预措施: BPM Core (Device)
Mitral stenosis
干预措施: BPM Core (Device)
Mitral regurgitation
干预措施: BPM Core (Device)
Tricuspid regurgitation
干预措施: BPM Core (Device)
Control
干预措施: BPM Core (Device)
结局指标
主要结局
Accuracy of valvular heart disease diagnosis using portable electronic stethoscope and machine learning-based diagnostic algorithms.
时间窗: from admission to discharge, up to 1 hour
Comparison between the algorithm diagnosis to those made by the clinicians using the collected heart auscultation data and echocardiogram results
次要结局
未报告次要终点
研究者
Wong Chun Ka
Clinical Assistant Professor
The University of Hong Kong