NCT04307030

Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Congenital Heart Disease in Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Heart Auscultation and Echocardiography	Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-12-31
• Completion: 2023-06-30
• First posted: 2020-03-13
• Last updated: 2023-04-21

Locations

16 sites across 1 country: China