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

Clalit Health Services

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran; Drug: alteplase; Procedure: endovascular

Study type: Observational

Funder types: Other

Identifiers

NCT02309970

GR 05 - 14

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Conservative

Description:

patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology

Treatment:

Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran

IV tPA

Description:

patient will receive intravenous thrombolysis treatment

Treatment:

Drug: alteplase

Endovascular treatment

Description:

patient who will receive endovascular treatment

Treatment:

Procedure: endovascular