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临床试验/NCT04307030
NCT04307030已完成不适用

Multi-center Study on Exploration and Application of Artificial Intelligence Technology-Assisted Heart Sound Recognition System in Children's Congenital Heart Disease Screening

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine16 个研究点 分布在 1 个国家目标入组 9,370 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kun Sun

Professor of Department of Pediatric Cardiology

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (16)

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