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Clinical Trials/NCT07194785
NCT07194785CompletedNot Applicable

Screening Program for Structural Heart Disease Among Primary and Secondary School Students in Ruyang County

Heart Health Research Center1 site in 1 country6,614 target enrollmentStarted: October 27, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
6,614
Locations
1
Primary Endpoint
Specificity of AI-enabled smart stethoscope

Study Overview

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.

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 traditional auscultation has limited accuracy in school or community settings due to examiner variability and limited access to echocardiography.

This study evaluates the performance of an artificial intelligence (AI)-enabled smart stethoscope for school-based screening of SHD in primary and secondary students in Ruyang County, China. The device integrates high-sensitivity acoustic sensors, noise-reduction technology, and deep learning algorithms to provide automated interpretations of heart sounds within seconds. Prior validation studies have demonstrated high sensitivity (>80%) and specificity (>90%) for congenital heart disease and up to 94% sensitivity and 98% specificity for rheumatic heart disease.

Screening will be conducted by trained personnel at four standard cardiac auscultation sites. Students with abnormal AI findings will undergo repeat testing and, if confirmed, will be referred for transthoracic echocardiography at Ruyang County People's Hospital. A subset of students with negative AI screens will also receive echocardiography to estimate false-negative rates.

Data will be analyzed using 2×2 contingency tables to compare AI screening results with echocardiography, and diagnostic performance metrics including sensitivity, specificity, positive predictive value, and negative predictive value will be calculated with 95% confidence intervals. Agreement between AI-assisted auscultation and echocardiography will be assessed using Cohen's kappa.

This study will provide evidence on the feasibility, accuracy, and scalability of AI-enabled smart stethoscopes for early SHD detection in school-based, low-resource settings.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
10 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

Screen group

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

Outcomes

Primary Outcomes

Specificity of AI-enabled smart stethoscope

Time Frame: From enrollment to the end of screen at 4 months.

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

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

Time Frame: From enrollment to the end of screen at 4 months.

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

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

Time Frame: From enrollment to the end of screen at 4 months.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Heart Health Research Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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