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

July 30, 2026 updated by: Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Anzhen Hospital
      • Chongqing, China
        • Children's Hospital Affiliated to Chongqing Medical University
      • Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
      • Guangzhou, China
        • Guangzhou Women And Children's Medical Center
      • Hangzhou, China
        • Children's Hospital Affiliated to Zhejiang Medical University
      • Hunan, China
        • Hunan Children's Hospital
      • Jinan, China
        • Shandong Provincial Hospital
      • Kunming, China
        • Kunming Children's Hospital
      • Lanzhou, China
        • Lanzhou University Second Hospital
      • Linyi, China
        • Linyi Hospital for Women and Children
      • Shanghai, China
        • Children's Hospital of Shanghai
      • Shanghai, China
        • Shanghai Children's Medical Center
      • Shiyan, China
        • Shiyan Taihe Hospital
      • Suzhou, China
        • Children's Hospital of Soochow University
      • Wenzhou, China
        • The Second Hospital Affiliated to Wenzhou Medical University
      • Wuhan, China
        • Wuhan Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pediatric population during outpatient service or hospitalization in ten pediatric medical centers in CHINA

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
0 ~ 18 years old children
Children During Outpatient or Hospitalization
Diagnostic test: Heart Auscultation and Echocardiography
Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receiver operating characteristic (ROC) of sensitivity
Time Frame: July 2020 to December 2021
ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation
July 2020 to December 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: KUN SUN, MD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-20-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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