Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke
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|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||March 2016|
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
subject in this group will receive intravenous tPA
patient who will receive endovascular treatment
Other Name: subject in this group will undergo mechanical thrombectomy
- The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke [ Time Frame: three month ]
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 ClinicalTrials.gov identifier (NCT number): NCT02309970
|Contact: Guy Raphaeli, MDfirstname.lastname@example.org|
|Contact: Ophir Keret, MDemail@example.com|
|Rabin Medical Center|
|Petach Tiqva, Hamerkaz, Israel, 49100|
|Contact: Guy Raphaeli, MD 972-50-4065626 firstname.lastname@example.org|
|Principal Investigator:||Guy Raphaeli, MD||Rabin Medical Center|