Comparing AI-assisted and traditional heart sound analysis for congenital heart disease screening
Efficacy Comparison Between Primary Care Physicians' Independent Auscultation and AI-assisted Auscultation for Congenital Heart Disease Screening in Patient-enriched Populations: a Randomized Controlled Trial
NA · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · NCT06791096
This study tests if using artificial intelligence to listen to children's heart sounds can help doctors find congenital heart disease more accurately than traditional methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 2 sites (Qinghai and 1 other locations) |
| Trial ID | NCT06791096 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of artificial intelligence-assisted auscultation compared to traditional methods used by primary care physicians for screening congenital heart disease (CHD) in children. The research involves collecting heart sounds using electronic stethoscopes and analyzing them with AI algorithms trained on a large dataset of heart sounds from both healthy children and those diagnosed with CHD. The goal is to determine if AI can improve the accuracy of CHD screening in a patient-enriched population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who are willing to undergo echocardiography for CHD screening.
Not a fit: Patients over 18 years old or those unable to cooperate with auscultation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the early detection of congenital heart disease in children, leading to timely interventions.
How similar studies have performed: Other studies have shown promise in using AI for medical diagnostics, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 0 to 18 years, with no gender restrictions. * Children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease. * Voluntary participation in this study and signing of an informed consent form. Exclusion Criteria: * Age greater than 18 years. * Children who are unable to undergo echocardiography or who do not cooperate with auscultation. * Participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.
Where this trial is running
Qinghai and 1 other locations
- Qinghai Provincial Women and Children's Hospital — Qinghai, China (NOT_YET_RECRUITING)
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Kun Sun, Phd
- Email: drsunkun@xinhuamed.com.cn
- Phone: 021-13601846338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Screening Tool, Artifical Intelligence, Randomised Controlled Trial, Auscultation for Clinical Evaluation