跳至主要内容
临床试验/NCT06633809
NCT06633809招募中不适用

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion: A Prospective Multicenter Registry Study

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月22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
200
试验地点
1
主要终点
modified Rankin Scale at 90 days

研究概览

简要总结

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

详细描述

It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.

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

  • Aged 18 years or older
  • Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
  • Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
  • Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP

排除标准

  • Any sign of intracranial hemorrhage on baseline CT/MR;
  • Seizures at stroke onset
  • Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL
  • Participation in any investigational study in the previous 30 days

结局指标

主要结局

modified Rankin Scale at 90 days

时间窗: 90 days

modified Rankin Scale at 90 days

acute neurological deterioration

时间窗: 24 hours

It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

次要结局

  • Incidence of symptomatic intracerebral hemorrhage(2-3 days)
  • patients with good outcome comparing the two treatment groups(90 days)

研究者

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

Jinhua Zhang

Prof.

Sir Run Run Shaw Hospital

研究点 (1)

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