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
1 other identifier
observational
9,370
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedAugust 3, 2026
May 1, 2024
3.8 years
March 11, 2020
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receiver operating characteristic (ROC) of sensitivity
ROC of sensitivity in CHD screening by different artificial intelligence algorithm and auscultation
July 2020 to December 2021
Study Arms (1)
0 ~ 18 years old children
Children During Outpatient or Hospitalization
Interventions
Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist
Eligibility Criteria
Pediatric population during outpatient service or hospitalization in ten pediatric medical centers in CHINA
You may qualify if:
- \~ 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.
You may not qualify if:
- ≥ 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Beijing Anzhen Hospital
Beijing, China
Children's Hospital Affiliated to Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Guangxi Medical University
Guangxi, China
Guangzhou Women and Children's Medical Center
Guangzhou, China
Children's Hospital Affiliated to Zhejiang Medical University
Hangzhou, China
Hunan Children's Hospital
Hunan, China
Shandong Provincial Hospital
Jinan, China
Kunming Children's Hospital
Kunming, China
Lanzhou University Second Hospital
Lanzhou, China
Linyi Hospital for Women and Children
Linyi, China
Children's Hospital of Shanghai
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Shiyan Taihe Hospital
Shiyan, China
Children's Hospital of Soochow University
Suzhou, China
The Second Hospital Affiliated to Wenzhou Medical University
Wenzhou, China
Wuhan Children's Hospital
Wuhan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KUN SUN, MD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Department of Pediatric Cardiology
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 13, 2020
Study Start
July 1, 2020
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
August 3, 2026
Record last verified: 2024-05