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

Study Overview
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Brief Summary
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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.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran
* Drug: alteplase
* Procedure: endovascular


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative<br>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<br>* subject in this group will receive oral treatment with anti platelet drug<br>* Other names: Aspirin, Plavix, Coumadin, Eliquis,Xarelto, Pradaxa, Sintrom;|
| IV tPA<br>patient will receive intravenous thrombolysis treatment | Drug: alteplase<br>* subject in this group will receive intravenous tPA<br>|
| Endovascular treatment<br>patient who will receive endovascular treatment | Procedure: endovascular<br> <br> * Other names: subject in this group will undergo mechanical thrombectomy;|

What is the study measuring?
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Primary Outcome Measures

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