Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,495
- 试验地点
- 1
- 主要终点
- Average change in LVEF between preliminary and final report
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 left ventricular ejection fraction 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
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory.
- •The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory.
排除标准
- •The study imaging studies will exclude transesophageal echocardiogram imaging.
- •The study will exclude cardiologists who decline to participate
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 Measurement of LVEF (Other)
Artificial Intelligence Annotation
In preliminary work, a novel AI algorithm developed to assess LVEF was shown to be more precise than human interpretation in 10,030 echocardiograms done at Stanford University (Ouyang et al. Nature, 2020). With randomization, a proportion of the preliminary interpretations will be done by AI technology and the study team will assess how different this preliminary interpretation is from the final interpretation.
干预措施: Automated annotation of the left ventricle through deep learning (Other)
结局指标
主要结局
Average change in LVEF between preliminary and final report
时间窗: 10 Minutes
Mean change in LVEF between preliminary and final report
Frequency of >5% change in LVEF between preliminary and final report
时间窗: 10 Minutes
Proportion of studies the LVEF is changed more than 5% in final report
次要结局
- Frequency cardiologist adjusts preliminary annotation(10 Minutes)
- Average change in LVEF between prior clinical report and final report(10 Minutes)
研究者
David Ouyang
Staff Physician
Cedars-Sinai Medical Center