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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
Sponsor:
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
Conservative
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

IV tPA
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 ]


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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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT02309970


Contacts
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Contact: Guy Raphaeli, MD 972-50-4065626 guyre@clalit.org.il
Contact: Ophir Keret, MD 972-3-9377080 ophirke@clalit.org.il

Locations
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Israel
Rabin Medical Center Not yet recruiting
Petach Tiqva, Hamerkaz, Israel, 49100
Contact: Guy Raphaeli, MD    972-50-4065626    guyre@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
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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
ClinicalTrials.gov Identifier: NCT02309970     History of Changes
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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Ischemia
Clopidogrel
Aspirin
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Rivaroxaban
Dabigatran
Apixaban
Tissue Plasminogen Activator
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors