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The PERFusion Use in Stroke Evaluation Study (PERFUSE)

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ClinicalTrials.gov Identifier: NCT01387113
Recruitment Status : Recruiting
First Posted : July 4, 2011
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Ischemic Stroke Other: Computed tomography perfusion imaging

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2011
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018
Groups and Cohorts

Group/Cohort Intervention/treatment
Acute ischemic stroke patients
All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset
Other: Computed tomography perfusion imaging
As per standard of care at CPMC


Outcome Measures

Primary Outcome Measures :
  1. Final infarct volume [ Time Frame: 24 hour post-thrombolysis ]

Secondary Outcome Measures :
  1. Large vessel occlusion on neuroimaging [ Time Frame: 24 hours post-thrombolysis ]
  2. NIHSS [ Time Frame: 24-hours from tPA adminsitration ]
  3. Symptomatic intracerebral hemorrhage post-thrombolysis [ Time Frame: 24 hours post-thrombolysis ]
  4. Modified Rankin Scale [ Time Frame: 3-months from tPA administration ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All acute ischemic stroke patients who present to the emergency room at CPMC who receive IV rt-PA within 6 hours of symptom onset
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387113


Locations
United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Katie Ponting, BS    415-600-1163    pontinK@cpmcri.org   
Principal Investigator: Nobl Barazangi, MD PhD         
Sponsors and Collaborators
California Pacific Medical Center Research Institute
California Pacific Medical Center
Investigators
Principal Investigator: Nobl Barazangi, MD, PhD CPMC
More Information

Additional Information:
Responsible Party: Nobl Barazangi, Medical Doctor, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01387113     History of Changes
Other Study ID Numbers: PERFUSE
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Nobl Barazangi, California Pacific Medical Center Research Institute:
stroke
tPA
Thrombolysis
rt-PA
Ischemic
CTP
Imaging
CT Perfusion Imaging
Perfusion
CTA
CT Angiography
Acute ischemic stroke
Acute stroke therapy
(AIS)

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia