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The PERFusion Use in Stroke Evaluation Study (PERFUSE)

This study is currently recruiting participants.
Verified March 2013 by California Pacific Medical Center Research Institute
Sponsor:
Collaborator:
California Pacific Medical Center
Information provided by (Responsible Party):
Nobl Barazangi, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01387113
First received: June 21, 2011
Last updated: March 20, 2013
Last verified: March 2013
History of Changes

June 21, 2011
March 20, 2013
May 2011
Not Provided
Final infarct volume [ Time Frame: 24 hour post-thrombolysis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01387113 on ClinicalTrials.gov Archive Site
  • Large vessel occlusion on neuroimaging [ Time Frame: 24 hours post-thrombolysis ] [ Designated as safety issue: No ]
  • NIHSS [ Time Frame: 24-hours from tPA adminsitration ] [ Designated as safety issue: No ]
  • Symptomatic intracerebral hemorrhage post-thrombolysis [ Time Frame: 24 hours post-thrombolysis ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale [ Time Frame: 3-months from tPA administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The PERFusion Use in Stroke Evaluation Study
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All acute ischemic stroke patients who present to the emergency room at CPMC who receive IV rt-PA within 6 hours of symptom onset
Ischemic Stroke
Other: Computed tomography perfusion imaging
As per standard of care at CPMC
Acute ischemic stroke patients
All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset
Intervention: Other: Computed tomography perfusion imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01387113
PERFUSE
No
Nobl Barazangi, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
California Pacific Medical Center
Principal Investigator: Nobl Barazangi, MD, PhD CPMC
California Pacific Medical Center Research Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP