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临床试验/NCT05779215
NCT05779215招募中不适用

The Multicenter, Prospective, Real-world Registry of Acute Ischemic Stroke With Large- or Medium-vessel Occlusion

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50,000
试验地点
1
主要终点
modified Rankin Scale (mRS) score

研究概览

简要总结

This study is designed to observe the treatment options in real-world clinical practice as well as the safety and efficacy of different treatment strategies.

详细描述

LOMEVO is a prospective, multicenter, real-world registry lasting for 10 years. A total of 50000 patients with large- or medium-vessel occlusion will be enrolled at approximately 30 centers around China.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The clinical diagnosis is acute ischemic stroke with large- or medium- vessel occlusion (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018)
  • Informed consent from the patient or surrogate

排除标准

  • No additional exclusion criteria

结局指标

主要结局

modified Rankin Scale (mRS) score

时间窗: 90±7 days

Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

次要结局

  • mRS 0-3(90±7 days)
  • Excellent functional outcome(90±7 days)
  • Change of National Institutes of Health Stroke Scale (NIHSS)(7 days)
  • Door-to-Puncture Time (DPT)(24 hours)
  • Good functional outcome(90±7 days)
  • Onset-to-recanalization time(24 hours)
  • Symptom-to-thrombolysis time (STT)(24 hours)
  • Door-to-Needle Time (DNT)(24 hours)
  • Door-to-Recanalization Time (DRT)(24 hours)
  • Puncture-to-recanalization time(24 hours)

研究者

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

Junwei Hao, MD

Director of Neurology Department

Xuanwu Hospital, Beijing

研究点 (1)

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