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临床试验/NCT04096248
NCT04096248已完成不适用

Non-Contrast CT vs CTP or MRI Selection vs Medical Management in Late Presentation of Large Vessel Occlusion Stroke, 6-24 Hours. A Multicenter Retrospective Study

Boston Medical Center19 个研究点 分布在 10 个国家目标入组 2,790 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,790
试验地点
19
主要终点
Change in patients' disability based on a Modified Rankin Scale

研究概览

简要总结

The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management.

Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

详细描述

Additional subgroup analysis that are planned include:

  1. Futile Reperfusion in the Extended Window.

We will evaluate clinical, imaging and time metric factors associated with successful reperfusion yet poor outcomes (modified Rankin 3-6) in the 6-24 hour window.

An evaluation of factors associated with symptomatic intracranial hemorrhage and mortality will be conducted. 2. Pre-Stroke disability.

  1. EVT patients treated in the extended window compared to Medical Management
  2. EVT patients treated in the extended window with pre-existing disability vs. those without pre-existing disability
  3. Intravenous Thrombolysis in the Extended Window

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Patients presenting 6-24 hours from last known well with large vessel occlusion stroke
  • ASPECTS score 5 or greater from last known well
  • January 1, 2014 to May 1, 2022

排除标准

  • Time last seen well to treatment <6 hours from last known well

结局指标

主要结局

Change in patients' disability based on a Modified Rankin Scale

时间窗: baseline, 90 days

The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. Lower scores correlate with less disability/dependence.

次要结局

  • Intracranial hemorrhage incidence(90 days)
  • Mortality rate(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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