The PERFusion Use in Stroke Evaluation Study

NCT01387113 | Completed

• 1 other identifier: PERFUSE
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

stroke; tPA; Thrombolysis; rt-PA; Ischemic; CTP; Imaging; CT Perfusion Imaging; Perfusion; CTA; CT Angiography; Acute ischemic stroke; Acute stroke therapy; (AIS)

Outcome Measures

Primary Outcomes (1)

• Final infarct volume

  24 hour post-thrombolysis

Secondary Outcomes (4)

• Large vessel occlusion on neuroimaging

  24 hours post-thrombolysis

• NIHSS

  24-hours from tPA adminsitration

• Symptomatic intracerebral hemorrhage post-thrombolysis

  24 hours post-thrombolysis

• Modified Rankin Scale

  3-months from tPA administration

Study Arms (1)

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

Computed tomography perfusion imaging OTHER

As per standard of care at CPMC

Acute ischemic stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Acute ischemic stroke
• ≥ 18 years old
• presentation up to 6 hours from time of onset of acute stroke symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead
• California Pacific Medical Center: collaborator

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Nobl Barazangi, MD, PhD

  CPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: July 4, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

US (1)