NCT01092819已完成不适用
Functional Outcome and Recovery After STROKE: The FIRST Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
研究概览
简要总结
Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •From 18 to 85 years of age.
- •Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1) from CT Angiography. Target vessel occlusion may include the anterior circulation.
- •Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
- •At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score greater than 10
- •Known core infarct volume assessed by CTP, CTA or DWI scans
排除标准
- •History of stroke in the past 3 months.
- •Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1
- •Known severe allergy to contrast media
- •Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg)
- •CT evidence of the following conditions before enrollment:
- •Significant mass effect with midline shift
- •Evidence of intracranial hemorrhage
- •Treated with endovascular therapy for acute stroke
- •Life expectancy less than 90 days
- •Participation in another clinical investigation that could confound the evaluation of the study
结局指标
主要结局
Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2.
时间窗: 90 days after presentation
次要结局
- Incidence of symptomatic and asymptomatic hemorrhage(Dishcharge and 90 days after presentation)
- • Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge.(Discharge and 90 days after presentation)
- All cause mortality(Dishcharge and 90 days after presentation)
研究者
研究点 (3)
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