The PERFusion Use in Stroke Evaluation Study (PERFUSE)

March 3, 2023 updated by: Nobl Barazangi, California Pacific Medical Center Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Final infarct volume
Time Frame: 24 hour post-thrombolysis
24 hour post-thrombolysis

Secondary Outcome Measures

Outcome Measure
Time Frame
Large vessel occlusion on neuroimaging
Time Frame: 24 hours post-thrombolysis
24 hours post-thrombolysis
NIHSS
Time Frame: 24-hours from tPA adminsitration
24-hours from tPA adminsitration
Symptomatic intracerebral hemorrhage post-thrombolysis
Time Frame: 24 hours post-thrombolysis
24 hours post-thrombolysis
Modified Rankin Scale
Time Frame: 3-months from tPA administration
3-months from tPA administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

California Pacific Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERFUSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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