Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Accuracy of Provider RHD Screening
研究概览
简要总结
The main goal of this project is to see if RADAR (Rapid AI-assisted Detection and Analysis of Rheumatic heart disease), which is a machine and deep-learning AI model, can help make rheumatic heart disease (RHD) screening easier to expand. Specifically, the project will test whether RADAR can screen as accurately-or more accurately-than current methods, and whether it can be used effectively in different low-resource settings. The aim is to show that RADAR could be adopted and used widely around the world.
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 (Care Provider)
盲法说明
Cardiologists who make up the adjudication panel.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employed at a participating ADUNU facility
- •Holds a designated role in the ADUNU program as a nurse screener
排除标准
- •None. The pragmatic trial design includes all eligible staff at participating facilities.
研究组 & 干预措施
Standard non-AI echocardiography
In the Standard non-AI Echocardiography arm, participants will receive the current standard of care under the ADUNU program, which includes a single parasternal long-axis view with black-and-white and color Doppler imaging. Providers have been trained to recognize mitral regurgitation greater than 1.5 or 2 cm, any aortic insufficiency, qualitatively reduced left ventricular systolic function, and pericardial effusion. Detection of any of these findings constitutes a screen positive, prompting referral for a confirmatory echocardiogram.
RADAR-AI-assisted echocardiography
In the RADAR Echocardiography arm, participants will undergo AI-assisted screening according to the well-established RADAR protocol including the same image acquisition protocol but interpreted by the tablet-based software based on two independent AI algorithms 1) RHD positive or negative and 2) mitral regurgitation jet length. Positive findings from either algorithm constitutes a screen positive. Providers may also refer for other concerns.
干预措施: AI assisted echocardiography (Diagnostic Test)
结局指标
主要结局
Accuracy of Provider RHD Screening
时间窗: 1 year
The number of correctly identified (positive or negative) screenings divided by the total number of exams.
次要结局
- Interpretation Sensitivity(6 months)