Multi-center Study on Exploration and Application of Artificial Intelligence Technology-Assisted Heart Sound Recognition System in Children's Congenital Heart Disease Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,370
- 试验地点
- 16
- 主要终点
- Receiver operating characteristic (ROC) of sensitivity
研究概览
简要总结
The objective of this study is to establish AI algorithm based on the deep learning to strengthen the ability to classify the heart murmurs of healthy people and different major or other subdivided congenital heart diseases(CHDs) and to evaluate the effectiveness of artificial intelligence technology-assisted heart sound recognition system (referred to as: Heart sound AI recognition system) for multi-center CHD screening.
详细描述
This is a multi-center cluster cross-sectional study in CHINA. Heart sounds will be collected by auscultation using an electronic stethoscope in children (0 ~ 18 years old) confirmed with or without CHDs by echocardiography during outpatient or hospitalization in 10 pediatric medical centers. Heart sounds will be visualized as phonocardiogram, and feature extraction will be done after classification of normal and abnormal heart sounds and labeling the characteristics of heart murmurs by pediatric cardiovascular specialists. Artificial intelligence algorithm (machine learning, deep learning, etc.) will be trained to build a heart sounds recognition system with the data mentioned above.We will use the receiver operating characteristic (ROC) curve to compare the ability of recognition and classification of abnormal heart sounds between different artificial intelligence algorithm. Taken the results of echocardiography as the gold standard, we will use the evaluation indexes,such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity of CHD screening between the AI recognition system and human cardiovascular pediatricians. Our target is to use artificial intelligence technology to assist heart auscultation for CHD screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0 ~ 18 years of age, regardless of gender ;
- •Children with or without congenital heart disease confirmed by echocardiography;
- •On the basis of informed consent,willing to cooperate with our group.
排除标准
- •≥ 18 years of age;
- •Children who can not undergo echocardiography or other related tests;
- •Subjects who refuse to join in, or who are unwilling to cooperate with the provision of diagnostic and therapeutic data for further analysis and research.
研究组 & 干预措施
0 ~ 18 years old children
Children During Outpatient or Hospitalization
干预措施: Heart Auscultation and Echocardiography (Diagnostic Test)
结局指标
主要结局
Receiver operating characteristic (ROC) of sensitivity
时间窗: July 2020 to December 2021
ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation
次要结局
未报告次要终点
研究者
Kun Sun
Professor of Department of Pediatric Cardiology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
