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Clinical Trials/NCT02309970
NCT02309970
Unknown
Not Applicable

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

Rabin Medical Center1 site in 1 country90 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran
Conditions
Ischemic Stroke
Sponsor
Rabin Medical Center
Enrollment
90
Locations
1
Primary Endpoint
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
March 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guy Raphaeli

Dr. Guy Raphaeli

Rabin Medical Center

Eligibility Criteria

Inclusion Criteria

  • NIHSS\>=8
  • up to 6 hours from event onset

Exclusion Criteria

  • mRS\>= 3 before the start of the event
  • life expectency \<1 year because other disability disease

Arms & Interventions

Conservative

patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology

Intervention: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran

IV tPA

patient will receive intravenous thrombolysis treatment

Intervention: alteplase

Endovascular treatment

patient who will receive endovascular treatment

Intervention: endovascular

Outcomes

Primary Outcomes

The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke

Time Frame: three month

Study Sites (1)

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