This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents. Eligible schools, rather than individual participants, will be randomly assigned to one of two screening approaches: independent cardiac auscultation by primary care physicians or AI-assisted cardiac auscultation. In both groups, primary care physicians will perform cardiac auscultation and record heart sounds. In the AI-assisted group, the physicians will also receive AI analysis of the recorded heart sounds to support their final screening decision. Participants will undergo medical history collection, cardiac auscultation, heart-sound recording, and echocardiography. Echocardiography and expert review will serve as the reference standard. The primary outcome is the sensitivity of each screening approach for detecting CHD that may require clinical intervention or specialist management. The study will also assess detection of all CHD, referral completion, confirmed diagnoses after referral, and related screening outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
10,000
During the school-based screening visit, a trained primary care physician will perform standardized cardiac auscultation and record the participant's heart sounds. The recorded heart sounds will be analyzed by an artificial intelligence-assisted auscultation system, which will provide automated analysis and decision-support feedback to the physician. The physician will consider the AI output together with the clinical examination and make the final screening and referral decision. The AI output is not a definitive diagnosis and will not replace echocardiography or specialist evaluation. No medication, surgery, or other therapeutic treatment will be administered as part of this intervention.
Qinghai Provincial Women and Children's Hospital
Qinghai, Qinghai, China
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
Specificity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
Sensitivity for Detecting All Congenital Heart Disease
Time frame: From enrollment to the end of treatment at 6 months
Positive Predictive Value for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
Referral Completion Rate
Time frame: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
Confirmed Diagnosis Rate After Referral
Time frame: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
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