The PERFusion Use in Stroke Evaluation Study

Ischemic Stroke Clinical Trial

— PERFUSE  

Official title:

Expanding the Time Window for IV Thrombolysis With Rt-PA in Acute Ischemic Stroke Patients Using Computed Tomography Perfusion Imaging: The PERFusion Use in Stroke Evaluation (PERFUSE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387113
• Other study ID #: PERFUSE
• Status: Completed
• Start date: May 2011
• Est. completion date: July 2022

Study information

• Verified date: March 2023
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Computed tomography perfusion imaging
As per standard of care at CPMC

Locations

Country	Name	City	State
United States	California Pacific Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	California Pacific Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final infarct volume		24 hour post-thrombolysis
Secondary	Large vessel occlusion on neuroimaging		24 hours post-thrombolysis
Secondary	NIHSS		24-hours from tPA adminsitration
Secondary	Symptomatic intracerebral hemorrhage post-thrombolysis		24 hours post-thrombolysis
Secondary	Modified Rankin Scale		3-months from tPA administration

External Links

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