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

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04307030
Collaborator
(none)
5,000
9
35.9
555.6
15.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Heart Auscultation and Echocardiography

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 Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Multi-center Study on Exploration and Application of Artificial Intelligence Technology-Assisted Heart Sound Recognition System in Children's Congenital Heart Disease Screening
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Receiver operating characteristic (ROC) of sensitivity [July 2020 to December 2021]

    ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bijie First Municipal Hospital Bijie China
2 Children's Hospital Affiliated to Chongqing Medical University Chongqing China
3 Children's Hospital Affiliated to Zhejiang Medical University Hangzhou China
4 Shandong Provincial Hospital Jinan China
5 Linhai Hospital for Women and Children Linhai China
6 Linyi Hospital for Women and Children Linyi China
7 Shanghai Children's Medical Center Shanghai China
8 Shiyan Taihe Hospital Shiyan China
9 The Second Hospital Affiliated to Wenzhou Medical University Wenzhou China

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kun Sun, Professor of Department of Pediatric Cardiology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04307030
Other Study ID Numbers:
  • XH-20-003
First Posted:
Mar 13, 2020
Last Update Posted:
Mar 13, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kun Sun, Professor of Department of Pediatric Cardiology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2020