A Prospective, School-Based, Cluster-Randomized Controlled Trial Comparing AI-Assisted Versus Independent Cardiac Auscultation by Primary Care Physicians for Detecting Congenital Heart Disease in Qinghai Province, China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
研究概览
简要总结
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents.
Eligible schools, rather than individual participants, will be randomly assigned to one of two screening approaches: independent cardiac auscultation by primary care physicians or AI-assisted cardiac auscultation. In both groups, primary care physicians will perform cardiac auscultation and record heart sounds. In the AI-assisted group, the physicians will also receive AI analysis of the recorded heart sounds to support their final screening decision.
Participants will undergo medical history collection, cardiac auscultation, heart-sound recording, and echocardiography. Echocardiography and expert review will serve as the reference standard. The primary outcome is the sensitivity of each screening approach for detecting CHD that may require clinical intervention or specialist management. The study will also assess detection of all CHD, referral completion, confirmed diagnoses after referral, and related screening outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents aged 0-18 years who are enrolled in a participating school in Qinghai Province and are eligible for the school-based congenital heart disease screening program.
- •Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable.
- •Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment.
- •Participant and/or parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information.
排除标准
- •Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts.
- •Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol.
- •Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment.
- •Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.
研究组 & 干预措施
Primary care physicians
AI + Primary care physicians
干预措施: AI-Assisted Cardiac Auscultation (Other)
结局指标
主要结局
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
时间窗: From enrollment to the end of treatment at 6 months
次要结局
- Specificity for Detecting Congenital Heart Disease Requiring Clinical Intervention(From enrollment to the end of treatment at 6 months)
- Sensitivity for Detecting All Congenital Heart Disease(From enrollment to the end of treatment at 6 months)
- Positive Predictive Value for Detecting Congenital Heart Disease Requiring Clinical Intervention(From enrollment to the end of treatment at 6 months)
- Referral Completion Rate(From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months)
- Confirmed Diagnosis Rate After Referral(From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months)
研究者
Kun Sun
Professor of Department of Pediatric Cardiology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine