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

NARecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

May 28, 2025

Study Completion Date

June 30, 2025

Conditions
Congenital Heart Disease (CHD)Screening ToolArtifical IntelligenceRandomised Controlled TrialAuscultation for Clinical Evaluation
Interventions
DIAGNOSTIC_TEST

AI-assisted auscultation

The study begins with non-blinded staff collecting medical histories and specialist physicians conducting face-to-face auscultations and assessments. Then, primary care doctors will conduct face-to-face auscultations and first assessments, and use AI-assisted stethoscopes to collect heart sounds following a set protocol. The AI model will analyze the data in real-time and provides an immediate diagnostic result, which is relayed back to the primary care physicians. Based on this, they will make a secondary assessment. All participants will undergo echocardiography.

DIAGNOSTIC_TEST

Independent auscultation

It includes medical history collection by non-blinded independent personnel, face-to-face auscultation and evaluations conducted by specialist physicians and primary care doctors separately. All participants will undergo echocardiography.

Trial Locations (2)

Unknown

NOT_YET_RECRUITING

Qinghai Provincial Women and Children's Hospital, Qinghai

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

lead

Kun Sun

OTHER