Smartphone-Based Use of Phonocardiography for Detection of Congenital Heart Disease: Diagnostic Performance Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
研究概览
简要总结
This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds.
Participants will have their heart sounds recorded during their normal attendance at the hospitals after consenting to participate in this study.
Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥ 6 years
- •Have undergone echocardiography within 3 years at their normal non-research hospital attendance
排除标准
- •Implanted active medical devices in the torso, such as pacemakers and defibrillators
- •Have purely non-congenital valvular heart disease
研究组 & 干预措施
Abnormal Echocardiography Diagnosis
Participants with abnormal echocardiography diagnosis within three years.
干预措施: Computer algorithms (Diagnostic Test)
Normal Echocardiography Diagnosis
Participants with normal echocardiography diagnosis within three years.
干预措施: Computer algorithms (Diagnostic Test)
结局指标
主要结局
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
时间窗: Day 0
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram \[PCG\]), measured in the form of sensitivity and specificity.
次要结局
- Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings(Day 0)
- Number of Adverse Events Reported by Participants or Child Participants' Parent/Legal Guardian During and at the End of Heart Sound Recording That are Determined to be Caused by This Study(Day 0)
研究者
Wong Chun Ka
Clinical Assistant Professor
The University of Hong Kong