The PERFusion Use in Stroke Evaluation Study

California Pacific Medical Center Research Institute48 enrolled

Overview

This is an open label single center phase II trial, evaluating the utility of 64 slice CT perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA) in AIS patients up to 6 hours after symptom onset.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ischemic Stroke

Interventions

Computed tomography perfusion imagingOTHER

As per standard of care at CPMC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute ischemic stroke * ≥ 18 years old * presentation up to 6 hours from time of onset of acute stroke symptoms Exclusion Criteria: * pregnancy * inability to receive CT scan * allergy to IV contrast * symptoms with full resolution * intracerebral hemorrhage * severe stroke which is classified as 'malignant' (hypodensity on noncontrast CT greater than 1/3 cerebral hemisphere) * premorbid mRS of \>3 * life expectancy of ≤3 months * any condition which, in the opinion of the investigator makes the subject unsuitable for study

Locations (1)

California Pacific Medical Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Final infarct volume

Time frame: 24 hour post-thrombolysis

Secondary Outcomes

Large vessel occlusion on neuroimaging

Time frame: 24 hours post-thrombolysis

NIHSS

Time frame: 24-hours from tPA adminsitration

Symptomatic intracerebral hemorrhage post-thrombolysis

Time frame: 24 hours post-thrombolysis

Modified Rankin Scale

Time frame: 3-months from tPA administration

Data from ClinicalTrials.gov

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