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

NCT07194785 | Completed

• 1 other identifier: RY-Screen
• Study Type: observational
• Target: 6,614
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Structural Heart Disease

Outcome Measures

Primary Outcomes (3)

• Specificity of AI-enabled smart stethoscope

  Proportion of students with a "screening negative" report by the smart stethoscope who are confirmed to have no structural heart disease by transthoracic echocardiography.

  From enrollment to the end of screen at 4 months.

• Positive Predictive Value (PPV) of AI-enabled smart stethoscope

  Proportion of students with two consecutive "screening positive" reports by the smart stethoscope who are confirmed to have structural heart disease by echocardiography.

  From enrollment to the end of screen at 4 months.

• Negative Predictive Value (NPV) of AI-enabled smart stethoscope

  Proportion of a random subset of students with a "screening negative" report by the smart stethoscope who are confirmed to have no structural heart disease by echocardiography.

  From enrollment to the end of screen at 4 months.

Study Arms (1)

Screen group

Diagnostic Test: AI-Assisted Cardiac Auscultation using the HearTech Smart Stethoscope

Interventions

AI-Assisted Cardiac Auscultation using the HearTech Smart Stethoscope DIAGNOSTIC_TEST

This intervention utilizes the HearTech smart stethoscope, where trained research personnel perform standardized examinations of four cardiac auscultation areas on subjects. The integrated AI algorithm analyzes heart sounds in real time and automatically generates reports. An initial positive detection triggers a repeat testing process, with the algorithm ultimately determining a positive screening result based on three detection outcomes (any two positive). This AI-assisted auscultation system is designed to achieve large-scale, standardized, and highly efficient preliminary heart murmur screening.

Screen group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from primary and secondary schools in Ruyang County, Henan Province, China. Screening will be conducted on-site at schools by trained personnel using AI-enabled smart stethoscopes. Students identified as having abnormal findings will be referred to the Cardiology Department of Ruyang County People's Hospital for confirmatory transthoracic echocardiography. A subset of students with normal screening results will also undergo echocardiography to estimate false-negative rates.

You may qualify if:

• School students aged 10-18 years.
• Able to cooperate with cardiac auscultation.
• Student and parent/guardian provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Health Research Center: lead

Study Sites (1)

Ruyang County People's Hospital

Luoyang, Henan, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 26, 2025
• Study Start: October 27, 2025
• Primary Completion: December 29, 2025
• Study Completion: January 5, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)