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

NCT07194785 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6614

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

AI-Assisted Cardiac Auscultation using the HearTech Smart Stethoscope

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.

Sponsors & Collaborators

  • Heart Health Research Center

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2025-12-29
Completion
2026-01-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194785 on ClinicalTrials.gov