AI Detection of Incidental Coronary Artery Calcium to Enhance Cardiovascular Disease Prevention: A Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention
研究概览
简要总结
AI INFORM is a multicenter randomized trial that will test the hypothesis that providing clinicians information on the presence and amount of coronary artery calcifications (CAC), will result in initiation or intensification of preventive therapies. The study will use a cloud-based artificial intelligence (AI) platform (Nanox.AI) that can analyze non contrast chest CT and estimate the amount of CAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40-75 with prior chest CT within last 3 years
排除标准
- •Prior coronary artery disease
- •Prior cancer
- •Other life-limiting condition
研究组 & 干预措施
Notification of Coronary Artery Calcification
Notification to providers of the presence of coronary artery calcification automatically detected by AI based device (software) on chest CT.
Recommendation of preventive therapy.
干预措施: Electronic health record-based notification of Nanox.AI Coronary Artery Calcification Assessment (Device)
Non-notification of Coronary Artery Calcification
No notification to providers of the presence of coronary artery calcification on chest CT automatically detected by AI based device (software) on chest CT.
No recommendation of preventive therapy.
结局指标
主要结局
Proportion of participants with initiation or intensification of lipid-lowering therapy after intervention
时间窗: 6 months
Initiation or intensification of therapy (yes/no) by 6 months after the intervention. Initiation: starting lipid-lowering therapy; intensification: increasing the dose of lipid-lowering therapy
次要结局
- Proportion of participants with major adverse cardiovascular events after intervention(12 months)
- Average change in LDL-C after intervention(12 months)
- Proportion of participants with downstream invasive or noninvasive testing after intervention(12 months)
- Proportion of participants with initiation or intensification of other preventive therapies after intervention(6 months)
研究者
Daniel Michael Huck, MD, MPH
Principal Investigator
Brigham and Women's Hospital