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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02309970
Recruitment Status : Unknown
Verified December 2014 by Guy Raphaeli, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 5, 2014
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):
Guy Raphaeli, Rabin Medical Center

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.

Condition or disease Intervention/treatment
Ischemic Stroke Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran Drug: alteplase Procedure: endovascular

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology
Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran
subject in this group will receive oral treatment with anti platelet drug
Other Name: Aspirin, Plavix, Coumadin, Eliquis,Xarelto, Pradaxa, Sintrom

patient will receive intravenous thrombolysis treatment
Drug: alteplase
subject in this group will receive intravenous tPA

Endovascular treatment
patient who will receive endovascular treatment
Procedure: endovascular
Other Name: subject in this group will undergo mechanical thrombectomy

Primary Outcome Measures :
  1. The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke [ Time Frame: three month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men and women admittedto the emergency room at Rabin Medical Center, Beilinson Campus and hospitalized at the neurology department.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02309970

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Contact: Guy Raphaeli, MD 972-50-4065626
Contact: Ophir Keret, MD 972-3-9377080

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Rabin Medical Center
Petach Tiqva, Hamerkaz, Israel, 49100
Contact: Guy Raphaeli, MD    972-50-4065626   
Sponsors and Collaborators
Rabin Medical Center
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Principal Investigator: Guy Raphaeli, MD Rabin Medical Center
Publications of Results:

Other Publications:
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Responsible Party: Guy Raphaeli, Dr. Guy Raphaeli, Rabin Medical Center Identifier: NCT02309970    
Other Study ID Numbers: GR 05 - 14
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tissue Plasminogen Activator
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors