CompletedNANCT06791109

Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

Sponsor: Kun Sun

Trial Details

ConditionCongenital Heart Disease (CHD), Screening Tool, Artificial Intelligence (AI), Cluster Randomized Trial, Auscultation for Clinical Evaluation
InterventionPrimary care physicians; AI + Primary care physicians
PhaseNA
StatusCompleted
Participants19,697
Est. Completion18 Nov 2025
Last Updated7 Apr 2026

Primary Outcome

Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria (Schools): * The school is of the type: kindergarten, primary school, junior high school, or senior high school. * The school has medical screening facilities and conditions that can support AI-assisted screening. * The area where the school is located has at least one primary healthcare institution willing to participate in this trial. * The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work. Exclusion Criteria (Schools): * More than half of the students in the school refuse to participate in the trial. * Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions. * Schools lacking medical screening facilities and conditions necessary for the implementation of screening. * Areas where there are no primary healthcare institutions willing to participate in this trial. * Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work. Inclusion Criteria (Individuals): * Children aged between 0 and 18 years, regardless of gender. * Children who agree to undergo echocardiography to determine the presence of congenital heart disease. * Individuals who voluntarily participate in this study and sign the informed consent form. Exclusion Criteria (Individuals): * Individuals over the age of 18. * Children who are unable to complete echocardiography or do not cooperate with auscultation. * Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research. * Participants who have received interventional or surgical treatment for CHD.

Trial Sites

Countries

China
View Registry Entry

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