AI-Assisted Smart Stethoscope Screening for Structural Heart Disease in School Students in Ruyang… (NCT07194785) | Clinical Trial Compass
CompletedNot Applicable
AI-Assisted Smart Stethoscope Screening for Structural Heart Disease in School Students in Ruyang County
China6,614 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Specificity of AI-enabled smart stethoscope
Timeframe: From enrollment to the end of screen at 4 months.
2
Positive Predictive Value (PPV) of AI-enabled smart stethoscope
Timeframe: From enrollment to the end of screen at 4 months.
3
Negative Predictive Value (NPV) of AI-enabled smart stethoscope
Timeframe: From enrollment to the end of screen at 4 months.