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临床试验/NCT03776877
NCT03776877Unknown不适用

Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

Hopital Foch16 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2018年6月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
Hopital Foch
入组人数
4,000
试验地点
16
主要终点
Clinical outcome

研究概览

简要总结

Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

研究设计

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

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

  • Age 18 and older (i.e., candidates must have had their 18th birthday)
  • Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the use of neuro-thrombectomy devices intended to restore blood flow
  • No upper or lower limits of the neurological severity at baseline (NIHSS).
  • With or without intravenous thrombolysis
  • Oral informed consent (patient and/or trustworthy person)
  • Non-inclusion Criteria:
  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection
  • Non-membership of a national insurance scheme

排除标准

  • 未提供

结局指标

主要结局

Clinical outcome

时间窗: Day 90

modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.

次要结局

  • ASPECT (Alberta Stroke Program Early CT score)(Day O)
  • Efficacy on revascularization (>= mTICI 2b)(Day 1)
  • Hematoma rate(Day 1)
  • Mortality rate(Day 90)
  • Parametric imaging(Day 0)
  • Imaging data(Day 1)
  • Blood sampling for research purpose(Day 0)
  • Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)(Day 1)
  • Hemorrhage evaluated by imagery(Day 0)
  • Efficacy on clinical outcome (mRS=0-1)(Day 90)
  • Complication rate(Day 0)
  • Efficacy on functional independence (mRS 0-2)(Day 90)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (16)

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