AI-Assisted Smart Stethoscope Screening for Structural Heart Disease in School Students in Ruyang County

The goal of this observational diagnostic study is to evaluate whether an artificial intelligence (AI)-enabled smart stethoscope can accurately detect structural heart disease in school-aged children and adolescents (10-18 years) in Ruyang County, China. The main questions it aims to answer are: Can the smart stethoscope reliably identify students with cardiac murmurs that indicate possible structural heart disease? How well do the sensitivity, specificity, and predictive values of the smart stethoscope compare with standard echocardiography? Researchers will compare AI-assisted stethoscope screening results with echocardiography (gold standard) to see if the device can be used as an effective early screening tool. Participants will: Undergo a heart sound screening using the AI-enabled smart stethoscope (3-5 minutes). If screening is positive, receive a free echocardiogram at Ruyang County People's Hospital. A small sample of students with negative screening results will also receive echocardiography to check for missed cases.

NCT Number	NCT07194785
Lead Sponsor	Heart Health Research Center
Conditions	Structural Heart Disease
Enrollment	6,614 participants
Start Date	2025-10-27
Primary Completion	2025-12-29 (estimated)
Study Completion	2026-01-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-03