The PERFusion Use in Stroke Evaluation Study | NCT01387113

Studies
The PERFusion Use in Stroke Evaluation Study

NCT01387113

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

Mar 6, 2023Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Computed tomography perfusion imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jul 2022Actual

Completion Date

Jul 2022Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jul 1, 2011

First Posted Date

Jul 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2023

Last Update Posted Date

Mar 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nobl Barazangi, Medical Doctor, California Pacific Medical Center Research InstitutePrincipal Investigator

Lead Sponsor

California Pacific Medical Center Research InstituteOTHER

Collaborators

Name	Class
California Pacific Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute ischemic stroke patients		All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset	Other: Computed tomography perfusion imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomography perfusion imaging	Other	As per standard of care at CPMC	Acute ischemic stroke patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Final infarct volume		24 hour post-thrombolysis

Secondary Outcomes

Measure	Description	Time Frame
Large vessel occlusion on neuroimaging		24 hours post-thrombolysis
NIHSS		24-hours from tPA adminsitration
Symptomatic intracerebral hemorrhage post-thrombolysis

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nobl Barazangi, MD, PhD	CPMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Pacific Medical Center		San Francisco	California	94115	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke
D007511	Ischemia

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003570	Cytidine Triphosphate

Ancestor Terms

ID	Term
D003597	Cytosine Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided