Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
研究概览
简要总结
CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. CTP helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment.
The use of CTP in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event.
The importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. But crucial evidence to support the predictive value of CTP to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.
Currently, the use of CTP is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking.
The current guidelines restrict the use of CTP trials and to patients that can't performed MRI scan.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NIHSS>=8
- •up to 6 hours from event onset
排除标准
- •mRS>= 3 before the start of the event
- •life expectency <1 year because other disability disease
研究组 & 干预措施
Conservative
patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology
干预措施: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran (Drug)
IV tPA
patient will receive intravenous thrombolysis treatment
干预措施: alteplase (Drug)
Endovascular treatment
patient who will receive endovascular treatment
干预措施: endovascular (Procedure)
结局指标
主要结局
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
时间窗: three month
次要结局
未报告次要终点
研究者
Guy Raphaeli
Dr. Guy Raphaeli
Rabin Medical Center
