NCT00238537CompletedPhase 2
Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Melbourne Health
- Enrollment
- 100
- Locations
- 27
- Primary Endpoint
- Primary Hypothesis - lesion growth
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- 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).
Investigators
Study Sites (27)
Loading locations...
Similar Trials
Completed
Not Applicable
Performance of direct thrombus imaging by MRI in the diagnosis of acute recurrent deep-vein thrombosisthrombosis of the leg10014523Deep venous thrombosisNL-OMON32134eids Universitair Medisch Centrum80
Not yet recruiting
Not Applicable
Advanced MRI scan in stroke patients to predict disability outcome.CTRI/2019/12/022404Kasturba Medical College
Not yet recruiting
Not Applicable
Thrombus characterization using MRI in intermediate-high-risk patients with pulmonary embolism and catheter-based interventional treatmentI26.0Pulmonary embolism with mention of acute cor pulmonaleDRKS00032538Klinikum rechts der Isar der Technischen Universität München100
Recruiting
Not Applicable
Thrombus Imaging and Treatment Analytics in NeurologyThrombus, BrainThrombosisNCT05663281Chinese PLA General Hospital100
Unknown
Not Applicable
A Longitudinal Study of Multimodal Resonance Imaging in Stroke PatientsStrokeNCT02024503Zhongda Hospital800
