The PERFusion Use in Stroke Evaluation Study (PERFUSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: January 29, 2014
Last verified: January 2014
  Purpose

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 Intervention
Ischemic Stroke
Other: Computed tomography perfusion imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Final infarct volume [ Time Frame: 24 hour post-thrombolysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Nobl Barazangi, Medical Doctor, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01387113     History of Changes
Other Study ID Numbers: PERFUSE
Study First Received: June 21, 2011
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014