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

December 4, 2014 updated by: Guy Raphaeli, Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
    • Hamerkaz
      • Petach Tiqva, Hamerkaz, Israel, 49100
        • Rabin Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • subject in this group will undergo mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
Time Frame: three month
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Guy Raphaeli, MD, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR 05 - 14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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