Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
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 regular clinic appointment 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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥22 years (adult)
- •Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment
- •Exclusion Criterion:
- •Implanted active medical devices in the torso, such as pacemakers and defibrillators
排除标准
- 未提供
结局指标
主要结局
Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
时间窗: Day 0
Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
时间窗: Day 0
Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
次要结局
- Sensitivity of ausculto™ Using Auscultation as Ground Truth(Day 0)
- Specificity of ausculto™ Using Echocardiography as Ground Truth(Day 0)
- Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth(Day 0)
- Sensitivity of ausculto™ Using Echocardiography as Ground Truth(Day 0)
- Specificity of ausculto™ Using Auscultation as Ground Truth(Day 0)
- Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth(Day 0)
- Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth(Day 0)
- Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures(Day 0 to Day 1)
- Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth(Day 0)
- Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth(Day 0)
- Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth(Day 0)
研究者
Wong Chun Ka
Clinical Assistant Professor
The University of Hong Kong