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Completed

NCT Number: NCT01387113

The PERFusion Use in Stroke Evaluation 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

California Pacific Medical Center

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed tomography perfusion imaging

Other

As per standard of care at CPMC

Primary outcomes

  1. Final infarct volume

    Time frame: 24 hour post-thrombolysis

Secondary outcomes

  1. Large vessel occlusion on neuroimaging

    Time frame: 24 hours post-thrombolysis

  2. NIHSS

    Time frame: 24-hours from tPA adminsitration

  3. Symptomatic intracerebral hemorrhage post-thrombolysis

    Time frame: 24 hours post-thrombolysis

  4. Modified Rankin Scale

    Time frame: 3-months from tPA administration

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Collaborators

  • California Pacific Medical Center

Registry information

Official study 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

Acronym: PERFUSE

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Jul 4, 2011
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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