Ischemic StrokePERFUSENCT01387113
The PERFusion Use in Stroke Evaluation Study
An observational study of Ischemic Stroke, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Computed tomography perfusion imaging
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Acute ischemic stroke
- ≥ 18 years old
- presentation up to 6 hours from time of onset of acute stroke symptoms
Who cannot join
- 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)
Show all 9Show fewer
- premorbid mRS of >3
- life expectancy of ≤3 months
- any condition which, in the opinion of the investigator makes the subject unsuitable for study
Trial locations and contacts
1 site in 1 country.
United States1 site
California Pacific Medical Center
San Francisco, California, 94115
About this study
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
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
- Being tested
- Computed tomography perfusion imaging
- Keywords
- stroke, tPA, Thrombolysis, rt-PA, Ischemic, CTP, Imaging, CT Perfusion Imaging, Perfusion, CTA, CT Angiography, Acute ischemic stroke, Acute stroke therapy, (AIS)
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography perfusion imagingOther
As per standard of care at CPMC
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients | All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset Receives: Other: Computed tomography perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final infarct volume
Measured: 24 hour post-thrombolysis
Secondary outcomes (4)
Large vessel occlusion on neuroimaging
Measured: 24 hours post-thrombolysis
NIHSS
Measured: 24-hours from tPA adminsitration
Symptomatic intracerebral hemorrhage post-thrombolysis
Measured: 24 hours post-thrombolysis
Modified Rankin Scale
Measured: 3-months from tPA administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- California Pacific Medical Center
- Responsible party
- Principal investigator, Nobl Barazangi, California Pacific Medical Center Research Institute
- Investigators
- Nobl Barazangi, MD, PhD, Principal investigator, CPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387113
- Sponsor's protocol ID
- PERFUSE
- Acronym
- PERFUSE
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2011
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01387113
- Acronym / sponsor ID
- PERFUSE / PERFUSE
- Conditions
- Ischemic Stroke
- Keywords
- stroke, tPA, Thrombolysis, rt-PA, Ischemic, CTP, Imaging, CT Perfusion Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- California Pacific Medical Center
- Study start
- May 2011
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients | – | Other: Computed tomography perfusion imagingAll acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- Acute ischemic stroke
- ≥ 18 years old
- presentation up to 6 hours from time of onset of acute stroke symptoms
Key exclusion criteria (9 listed)
- pregnancy
- inability to receive CT scan
- allergy to IV contrast
- symptoms with full resolution
- intracerebral hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography perfusion imagingAs per standard of care at CPMC | Other | Acute ischemic stroke patients |
Primary outcome
Final infarct volume
Time frame: 24 hour post-thrombolysis
4 secondary outcomes
Large vessel occlusion on neuroimaging
Time frame: 24 hours post-thrombolysis
NIHSS
Time frame: 24-hours from tPA adminsitration
Symptomatic intracerebral hemorrhage post-thrombolysis
Time frame: 24 hours post-thrombolysis
Modified Rankin Scale
Time frame: 3-months from tPA administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobl Barazangi, MD, PhD principal investigator
CPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final infarct volume (time frame: 24 hour post-thrombolysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.