Status:
NOT_YET_RECRUITING
AI-Assisted Smart Stethoscope Screening for Structural Heart Disease in School Students in Ruyang County
Lead Sponsor:
Heart Health Research Center
Conditions:
Structural Heart Disease
Eligibility:
All Genders
10-18 years
Brief Summary
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 ...
Detailed Description
Structural heart disease (SHD), including congenital and acquired cardiac abnormalities, is a leading cause of morbidity in children and adolescents. Cardiac murmurs are common clinical signs, but tra...
Eligibility Criteria
Inclusion
- School students aged 10-18 years.
- Able to cooperate with cardiac auscultation.
- Student and parent/guardian provide written informed consent.
Exclusion
- Student or parent/guardian declines participation.
- Inability or unwillingness to follow screening procedures or cooperate with cardiac auscultation.
- Refusal to undergo standard transthoracic echocardiography or cardiology evaluation.
- Previously diagnosed structural heart disease.
- Chest wall deformities or skin conditions that may interfere with auscultation.
- Fever ≥37.5 °C on the day of examination, or severe developmental delay or other conditions preventing cooperation with the examination.
Key Trial Info
Start Date :
October 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT07194785
Start Date
October 20 2025
End Date
March 31 2026
Last Update
September 26 2025
Active Locations (1)
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1
Ruyang County People's Hospital
Luoyang, Henan, China