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

• Conditions: Ischemic Stroke
• Interventions: Procedure: endovascular; Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran; Drug: alteplase

• Registration Number: NCT02309970
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-05
• Last Update Posted: 2014-12-05
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular treatment	endovascular	patient who will receive endovascular treatment
Conservative	acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran	patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology
IV tPA	alteplase	patient will receive intravenous thrombolysis treatment

Primary Outcome Measures

Name	Time	Method
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke	three month

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tiqva, Hamerkaz, Israel