Ischemic Stroke
Conditions
Keywords
stroke, tPA, Thrombolysis, rt-PA, Ischemic, CTP, Imaging, CT Perfusion Imaging, Perfusion, CTA, CT Angiography, Acute ischemic stroke, Acute stroke therapy, (AIS)
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.
Interventions
As per standard of care at CPMC
Sponsors
California Pacific Medical Center
California Pacific Medical Center Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final infarct volume | 24 hour post-thrombolysis |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed