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Completed

NCT Number: NCT06791109

"SOUND" Trial: Study of On-site Use of Novel AI-assisted Diagnostics in CHD Screening

This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.

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Key information

Conditions

Congenital Heart Disease (CHD) Artificial Intelligence (AI) Auscultation for Clinical Evaluation Cardiovascular Abnormalities Cardiovascular Diseases Cluster Randomized Trial Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Screening Tool

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qinghai Provincial Women and Children's Hospital

Xining, Qinghai, 810007, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Schools):

  • The school is of the type: kindergarten, primary school, junior high school, or senior high school.
  • The school has medical screening facilities and conditions that can support AI-assisted screening.
  • The area where the school is located has at least one primary healthcare institution willing to participate in this trial.
  • The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.

Exclusion criteria

(Schools):

  • More than half of the students in the school refuse to participate in the trial.
  • Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
  • Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
  • Areas where there are no primary healthcare institutions willing to participate in this trial.
  • Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.

Inclusion criteria

(Individuals):

  • Children aged between 0 and 18 years, regardless of gender.
  • Children who agree to undergo echocardiography to determine the presence of congenital heart disease.
  • Individuals who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

(Individuals):

  • Individuals over the age of 18.
  • Children who are unable to complete echocardiography or do not cooperate with auscultation.
  • Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research.
  • Participants who have received interventional or surgical treatment for CHD.

Treatment and study plan

Primary care physicians

Diagnostic Test

For participants in Group A, a nonblinded independent staff member will first collect medical history, followed by sequential auscultation and CHD assessment by a specialist physician and a primary care physician, with an echocardiogram performed last.

AI + Primary care physicians

Diagnostic Test

For participants in Group B, after medical history collection, both a specialist physician and a primary care physician will perform auscultation and CHD assessment. Subsequently, the primary care physician will use an electronic stethoscope to collect heart sound data according to the protocol and upload the recordings to a cloud platform. The AI model will analyze the data on the cloud platform and provide a diagnostic result within 5-10 seconds for the primary care physician's reference. The primary care physician may reassess the findings based on the AI model's feedback, and the participant will then undergo an echocardiogram.

Primary outcomes

  1. Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. Sensitivity of Auscultation in CHD Detection: AI model & Experienced Cardiologists' Independent Auscultatio

    Time frame: From enrollment to the end of treatment at 6 months

  2. Specificity of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation

    Time frame: From enrollment to the end of treatment at 6 months

  3. Accuracy of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Care Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation

    Time frame: From enrollment to the end of treatment at 6 months

  4. The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes

    Time frame: From enrollment to the end of treatment at 6 months

Other outcomes

  1. Incidence rates of CHD in children across different regions of Qinghai Province

    Time frame: From enrollment to the end of treatment at 6 months

Sponsors and collaborators

Lead sponsor

Kun Sun

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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