Stroke
Conditions
Keywords
Stroke, Collateral status, Endovascular treatment
Brief summary
Based on the results of recent randomized controlled trials, current international guidelines recommend the initiation of endovascular treatment within 6 hours of symptom onset for acute ischemic stroke. Endovascular treatment may be beneficial in selected patients beyond 6 hour time window. In particular, treatment response to endovascular therapy may be greatly influenced by pretreatment collateral status. The aim of this study is to evaluate whether MRI-based collateral imaging (the Fast Analysis SysTem for COLLaterals, 'FAST-COLL') is feasible and can predict the response to endovascular treatment in a wide range of patients with acute ischemic stroke .
Interventions
Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent
Sponsors
Study design
Eligibility
Inclusion criteria
* Acute ischemic stroke * Age 20 years and older * Disabling stroke defined as a baseline NIHSS \> 5 at the time of arrival * Onset (last-seen-well) time to endovascular treatment time \< 12 hours * Confirmed symptomatic intracranial occlusion, based on CT or MR angiography, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs) * Signed informed consent or appropriate signed deferral of consent where approved
Exclusion criteria
* Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion. * Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic * Unable to undergo MRI (contraindicated or poor cooperation) * Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient * Pregnant females as determined by positive urine hCG test or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-days functional outcome | 90-days | 90-days modified Rankin Scale ≤ 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early neurologic improvement | 24 hours | An 8-point or more improvement on the NIH score when comparing the baseline score or a NIHSS score of 0-1, at 24 hours. |
| Symptomatic hemorrhagic transformation | During initial admission | Occurrence of an increase in the National Institutes of Health Stroke Scale (NIHSS) score of 4 or more points in the setting of local or remote parenchymal hematoma. |
| Successful recanalization | within 24 hours of symptom onset | Defined as modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b |
Countries
South Korea