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Completed

NCT Number: NCT06791096

Efficacy Comparison Between Primary Care Physicians' Independent Auscultation and AI-assisted Auscultation for Congenital Heart Disease Screening in Patient-enriched Populations: A Randomized Controlled Trial

In recent years, the application of artificial intelligence (AI) in the healthcare domain has witnessed a significant surge, with deep learning emerging as a potent force in the medical field. Deep learning algorithms possess the remarkable ability to automatically extract intricate features and patterns, thereby facilitating highly accurate heart sound recognition. Drawing on this technological advancement, Professor Sun Kun and his research team from Xinhua Hospital, in collaboration with numerous centers spanning across China, have been diligently investigating the development and application of AI-assisted heart sound recognition for congenital heart disease (CHD) screening.

Utilizing electronic stethoscopes to meticulously collect heart sounds, and harnessing AI algorithms to analyze extensive datasets comprising heart sounds from both children diagnosed with CHD and those who are healthy, the system has been trained to adeptly differentiate between normal and pathological murmurs. The current iteration of the system boasts an impressive accuracy and sensitivity rate of 90%.

This study is designed as a randomized controlled trial (RCT) to be conducted at Shanghai Xinhua Hospital and Qinghai Provincial Women and Children's Hospital. The primary objective is to demonstrate the superiority of AI-assisted primary care physicians in identifying CHD over primary care physicians working independently. This will be achieved by conducting a comparative analysis of the performance of AI-assisted physicians versus their unassisted counterparts, thereby substantiating the model's practical applicability. Through an ongoing process of refinement and widespread application, this pioneering research endeavors to empower a diverse range of medical professionals, including general practitioners, child health physicians, and non-cardiovascular specialists, with the transformative capabilities of AI-assisted electronic auscultation. The ultimate goal is to elevate the standard of pediatric care across the nation.

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Key information

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, Qinghai, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 0 to 18 years, with no gender restrictions.
  • Children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease.
  • Voluntary participation in this study and signing of an informed consent form.

Exclusion criteria

  • Age greater than 18 years.
  • Children who are unable to undergo echocardiography or who do not cooperate with auscultation.
  • Participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.

Treatment and study plan

AI-assisted auscultation

Diagnostic Test

The study begins with non-blinded staff collecting medical histories and specialist physicians conducting face-to-face auscultations and assessments. Then, primary care doctors will conduct face-to-face auscultations and first assessments, and use AI-assisted stethoscopes to collect heart sounds following a set protocol. The AI model will analyze the data in real-time and provides an immediate diagnostic result, which is relayed back to the primary care physicians. Based on this, they will make a secondary assessment. All participants will undergo echocardiography.

Independent auscultation

Diagnostic Test

It includes medical history collection by non-blinded independent personnel, face-to-face auscultation and evaluations conducted by specialist physicians and primary care doctors separately. All participants will undergo echocardiography.

Primary outcomes

  1. Sensitivity of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation

    Time frame: From enrollment to the end of treatment at 3 months

Secondary outcomes

  1. Specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation

    Time frame: From enrollment to the end of treatment at 3 months

  2. Specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & AI-Assisted Auscultation By Primary Care Physician

    Time frame: From enrollment to the end of treatment at 3 months

  3. Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI Model

    Time frame: From enrollment to the end of treatment at 3 months

  4. Specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & Primary Care Physicians' Independent Auscultation

    Time frame: From enrollment to the end of treatment at 3 months

  5. Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & AI Model

    Time frame: From enrollment to the end of treatment at 3 months

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

    Time frame: From enrollment to the end of treatment at 3 months

Sponsors and collaborators

Lead sponsor

Kun Sun

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
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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