Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- NIHSS Score
研究概览
简要总结
The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to benefit from endovascular therapy.
The project has two main parts. During the first part, the investigators propose to develop a fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate brain maps of the ischemic core and penumbra. There will be no patient enrollment in part one of this project.
During the second part, the investigators aim to demonstrate that physicians in the emergency setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately predict response to recanalization in stroke patients undergoing revascularization. To achieve this aim the investigators will conduct a prospective cohort study of 240 consecutive stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be conducted at four sites (Stanford University, St Luke's Hospital, University of Pittsburgh Medical Center, and Emory University/Grady Hospital). Patients will have an early follow-up MRI scan within 12+/-6 hours to assess reperfusion and a late follow-up MRI scan at day 5 to determine the final infarct.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •be 18 or older;
- •have a clinical diagnosis of ischemic stroke and a score of 5 or more points on the NIHSSS;
- •be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke (either as primary therapy or as adjuvant therapy following intravenous tPA treatment);
- •be scheduled to have a standard CT including perfusion imaging and CT angiography of the circle of Willis (CTA) prior to IA therapy;
- •begin intra-arterial thrombectomy within 90 minutes of completion of the CT scan and within 18 hours of symptom onset. (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed); and
- •have provided informed consent.
排除标准
- •have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
- •are pregnant.
结局指标
主要结局
NIHSS Score
时间窗: 30 Day
A "favorable clinical response", defined as an 8-point or more improvement on the NIH score when comparing the baseline score to the 30-day score or a 30-day NIH score of 0-1, will be the primary endpoint for the study
次要结局
- modified Rankin Score(90 day)
研究者
Maarten Lansberg
Assistant Professor
Stanford University