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临床试验/NCT02072681
NCT02072681已完成不适用

Mild and Rapidly Improving Stroke Study

University of Miami97 个研究点 分布在 1 个国家目标入组 2,175 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,175
试验地点
97
主要终点
Proportion of patients not independent at 90 days

研究概览

简要总结

The objective of this study is to determine the 90-day outcomes of mild and rapidly improving 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild or spontaneously rapidly improving ischemic stroke confirmed by neuroimaging
  • Arrival to hospital within 4.5 hours of symptom onset
  • Willing to provide consent
  • Available for a telephone interview at 30 and 90 days

排除标准

  • Onset >4.5 hours
  • Unable to provide informed consent (patient or legally appointed representative
  • Premorbid modified Rankin Scale >1
  • Unavailable by telephone for follow-up

结局指标

主要结局

Proportion of patients not independent at 90 days

时间窗: 90 days

The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days

次要结局

  • Proportion of patients with dependence or disability in activities of daily living at 90 days(90 days)
  • Symptomatic intracranial hemorrhage due to Alteplase(36 hours)
  • Quality of life by the EuroQOL EQ-5D(90 days)
  • Stroke disability by the Stroke-Impact Scale-16(90 days)
  • Proportion of patients not independent at 30 days(30 days)
  • Independence with Activities of Daily Living by the Barthel Index(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Romano, MD

Professor of Clinical Neurology

University of Miami

研究点 (97)

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