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临床试验/NCT02309970
NCT02309970Unknown不适用

Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Raphaeli

Dr. Guy Raphaeli

Rabin Medical Center

研究点 (1)

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