Artificial Intelligence Echocardiogram Interpretation for Systematic Integration and Guided Healthcare Transformation (The AI ECHO INSIGHT Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.
研究概览
简要总结
The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.
The main questions it aims to answer is to:
- Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows.
- Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow.
- To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.
排除标准
- •Known Congenital heart disease study
- •Known Ventricular assist device
- •Limited transthoracic echocardiogram study
- •Transesophageal echocardiogram study
- •Stress echocardiogram study
研究组 & 干预措施
AI-Assisted Interpretation
In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.
干预措施: AI-Assisted Echocardiogram Interpretation (Other)
Sonographer-Assisted Interpretation
In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.
干预措施: Sonographer-Assisted Echocardiogram Interpretation (Other)
Cardiologist-Only Interpretation
In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.
干预措施: Cardiologist-Only Echocardiogram Interpretation (Other)
结局指标
主要结局
Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.
时间窗: 6 months
The accuracy rate is defined as the proportion of transthoracic echocardiogram (TTE) studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation. We will assess the accuracy rate in the AI-assisted arm for non-inferiority versus the pooled accuracy rate across both the sonographer-assisted and cardiologist-only arms. The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
次要结局
- Secondary Measures of Accuracy (Superiority Analyses)(6 months)
- Accuracy Compared with Historical Cardiologist Interpretations(6 months)
- Accuracy Compared with Consensus Cardiologist Interpretations(6 months)
- Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only)(6 months)
- Evaluation requiring two-grade change in valve disease severity as substantial change(6 months)
- Cardiologist Overread Time (Efficiency)(6 months)
- Blinding(6 months)
研究者
David Ouyang
Principal Investigator
Kaiser Permanente