Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET)
- Conditions
- Stroke
- Registration Number
- NCT00238537
- Lead Sponsor
- Melbourne Health
- Brief Summary
To determine whether the extent of the ischemic penumbra apparent on perfusion-diffusion MRI can be used to identify patients who would respond positively and safely to tissue plasminogen activator (tPA) beyond 3 hours post-stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients who present:
- with acute hemispheric stroke within 3-6 hours of onset,
- have at least moderate limb weakness,
- a National Institute of Health Stroke Scale (NIHSS) score > 4,
- had a pre-stroke modified Rankin Scale (MRS) score of 0 - 2
- and who are able to undergo CT and MRI, are eligible for this study.
- Females who are pregnant or breast-feeding,
- persons who have CT-verified hemorrhagic stroke, major ischemia ( > 33% of the middle cerebral artery (MCA) territory infarcted), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, intracranial neoplasm that is terminal or poses a risk of hemorrhage ,
- are comatose or severely obtunded with fixed eye deviation and complete hemiplegia,
- have had another stroke within the past 6 weeks,
- have had a seizure prior to the administration of the study drug,
- have active peptic ulceration, bleeding diatheses, previous intracerebral hemorrhage,
- blood pressure > 185/110,
- major surgery or trauma within the past 30 days, or any other contraindications to tPA
- have a presumed septic embolus or a myocardial infarction within the past 30 days
- blood glucose values are < 2.8 or > 22.0 mmol/L,
- pacemakers, aneurysm clips, implanted devices, claustrophobia, or any other contraindications to MRI,
- decreased consciousness,
- rapid clinical improvement,
- confounding neurological condition (e.g. dementia),
- any other life-threatening illness, or who are participating in another clinical trial, will be excluded from this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary Hypothesis - lesion growth In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.
- Secondary Outcome Measures
Name Time Method Secondary Hypotheses In the non-penumbral group, lesion growth will be lower and will not be attenuated by tPA. Favourable functional outcome (mRS 0-2) will be more likely in patients with penumbra receiving tPA. That the proportion of patients achieving good neurological outcome (an 8 point improvement in NIH-SS or outcome NIH-SS of 0, 1) will be greater in those patients with a penumbra receiving tPA. Symptomatic hemorrhagic transformation (sICH) will be predicted by the size of the baseline DWI volume in those patients receiving tPA. Reperfusion (greater than 90% PWI lesion reduction, or recanalisation on MRA, between the acute and sub-acute interval), will be increased (in patients with penumbra) receiving tPA. In patients with malignant mismatch (Definition DWI 100ml or more and / or PWI 100ml or more) there will be unfavourable clinical outcome (even if there is attenuation of growth).
Trial Locations
- Locations (14)
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hunter New England Area Health Service
🇦🇺Newcastle, New South Wales, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Flinders Medical Center
🇦🇺Adelaide, South Australia, Australia
Austin Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Cliniques Universitaires St Luc
🇧🇪Brussels, Belgium
Box Hill Hospital
🇦🇺Melbourne, Victoria, Australia
St Vincents Hospital
🇦🇺Melbourne, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia