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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Congenital Heart Disease in Children

Treatments

Diagnostic Test: Heart Auscultation and Echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT04307030
XH-20-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. 0 ~ 18 years of age, regardless of gender ;
  2. Children with or without congenital heart disease confirmed by echocardiography;
  3. On the basis of informed consent,willing to cooperate with our group.

Exclusion criteria

  1. ≥ 18 years of age;
  2. Children who can not undergo echocardiography or other related tests;
  3. 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.

Trial design

5,000 participants in 1 patient group

0 ~ 18 years old children
Description:
Children During Outpatient or Hospitalization
Treatment:
Diagnostic Test: Heart Auscultation and Echocardiography

Trial contacts and locations

16

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Central trial contact

KUN SUN, MD

Data sourced from clinicaltrials.gov

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