The PERFusion Use in Stroke Evaluation Study

NCT ID: NCT01387113

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute ischemic stroke patients

All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset

Computed tomography perfusion imaging

Intervention Type OTHER

As per standard of care at CPMC

Interventions

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Computed tomography perfusion imaging

As per standard of care at CPMC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center

OTHER

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Nobl Barazangi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nobl Barazangi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CPMC

Locations

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California Pacific Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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PERFUSE

Identifier Type: -

Identifier Source: org_study_id

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