MR-based Collateral Imaging to Predict Response to Endovascular Treatment of Stroke (FAST-COLL Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 90-days functional outcome
研究概览
简要总结
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
90-days functional outcome
时间窗: 90-days
90-days modified Rankin Scale ≤ 2
次要结局
- Early neurologic improvement(24 hours)
- Symptomatic hemorrhagic transformation(During initial admission)
- Successful recanalization(within 24 hours of symptom onset)
研究者
Oh Young Bang
Professor
Samsung Medical Center