Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 2
- 主要终点
- Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)
研究概览
简要总结
After onset of Acute Ischemic Stroke (AIS), every minute of delay to treatment reduces the likelihood of a good clinical outcome. A key delay occurs in the time between completion of computed tomography (CT) angiography of the head and neck and interpretation in the setting of AIS care.
The purpose of this study is to assess the effect of incorporating Viz.AI software, which via via a machine-learning algorithm performs artificial intelligence-based automated detection of large vessel occlusions (LVO) on CT angiography (CTA) images and alerts the AIS care team (diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, per routine standard of care). The hypothesis is that integration of the software into the AIS care pathway will reduce delays in treatment. A cluster-randomized stepped-wedge trial will be performed across 4 hospitals in the greater Houston area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male or Female
- •18 years of age or older.
- •Patients who present to the emergency department with signs and/or symptoms concerning for acute ischemic stroke.
- •Patients who undergo CT angiography imaging
- •Patients determined to have a large vessel occlusion acute ischemic stroke. This determination will be made based on official radiology report for the CT angiography imaging.
排除标准
- •Patients with incomplete data on the electronic medical record.
结局指标
主要结局
Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)
时间窗: from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)
次要结局
- Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2(90 days)
- Number of Patients Who Received With Endovascular Stroke Therapy(at the time of initiation of endovascular stroke therapy)
- Hospital Length of Stay(From the time of admission to the hospital to the time of discharge (about 7 days))
- Number of Patients With Intracranial Hemorrhage (ICH)(From the time of admission to the hospital to the time of discharge (about 7 days))
研究者
Sunil A. Sheth
Associate Professor
The University of Texas Health Science Center, Houston