EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
研究概览
简要总结
To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Measurements shown in Picture Archiving and Communication System (PACS) without direct communication between sonographer and cardiologist. Annotations are shown without identifiers on how the annotations were done. Cardiologists are blinded to source of preliminary interpretation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sonographers and cardiologists at CSMC Echocardiography Lab
- •All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab
排除标准
- •transthoracic echocardiogram studies not able to be measured by sonographers in run in period
研究组 & 干预措施
Sonographer Annotation
Currently, sonographer technicians provide preliminary interpretations prior to validation and overreading by cardiologists. This staggered, stepwise evaluation allows for the introduction of AI decision support with minimal impact on patient care. Physicians are already used to adjusting the preliminary report given the variable training of sonographers and on the lookout for changes, variation, or adjustments that need to be made.
干预措施: Sonographer Evaluation (Diagnostic Test)
Artificial Intelligence Annotation
A novel AI algorithm developed to assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The AI will provide preliminary assessments for cardiologist evaluation.
干预措施: AI Evaluation (Diagnostic Test)
结局指标
主要结局
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
时间窗: 10 Minutes
Proportion of significant difference in LVIDd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd
时间窗: 10 Minutes
Proportion of significant difference in IVSd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd
时间窗: 10 Minutes
Proportion of significant difference in LVPWd between preliminary to final assessment
mean absolute error (MAE) of IVSd between preliminary to overread between the two arms
时间窗: 10 Minutes
Measurement difference of IVSd between preliminary to final assessment
mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms
时间窗: 10 Minutes
Measurement difference of LVPWd between preliminary to final assessment
mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms
时间窗: 10 Minutes
Measurement difference of LVIDd between preliminary to final assessment
次要结局
- mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness(10 Minutes)
- Time to complete each imaging study(10 Minutes)
- Effects of the AI systems integration with computer-human interaction (Blinding)(10 Minutes)
研究者
David Ouyang
Staff Physician
Cedars-Sinai Medical Center