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

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02309970

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Ischemic Stroke	Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran Drug: alteplase Procedure: endovascular

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	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

Arm

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