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临床试验/NCT05644938
NCT05644938Enrolling By Invitation不适用

Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke Trial

Can Tho Stroke International Services Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
2
主要终点
Door-to-reperfusion times

研究概览

简要总结

Time is one of the most important in the decision of treatment of acute ischemic stroke. The optimal One-stop management from admission to recanalization associated with reduction of in-hospital times. The development of flat-detector computed tomography perfusion capable angio-suite allowed One-stop management to be improved treatment time better and better. To compare One-stop management versus our standard workflow in shortening door-to-recanalization time.

详细描述

Acute ischemic stroke is one of the diseases associated with stroke onset time, especially in the case of large vessel occlusion within 6 hours. This is the reason why endovascular reperfusion therapy (mechanical thrombectomy, angioplasty, stent,...) is recommended to be performed as soon as possible in the comprehensive stroke centers. The successful recanalization within 6 hours demonstrated the efficacy that helps to improve the functional outcome by trials. Besides, the strategies shortening time from admission to successful recanalization are essential for the treatment of acute ischemic stroke due to large vessel occlusion. Nevertheless, the optimizing door-to-groin puncture and door to recanalization Time are the great challenge to benefit most patients with the endovascular therapy. In recent years, the One - stop management (direct transport to the angiosuite workflow) which means that the recanalization therapy is considered to perform immediately based on the diagnostic angiograms and perfusion maps relating to acute ischemic stroke caused by large vessel occlusion by the flat-detector computed tomography at the angiosuite at the same time. We hypothesized that one-stop management is feasible and reduces more intrahospital time delays than our standard workflow previously published.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients are only blinded to the allocation.

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

  • Acute ischemic stroke in the anterior circulation caused by large vessel occlusion.
  • National Institute of Health Stroke Scale (NIHSS) ≥
  • Premorbid modified Rankin Scale (mRS) ≤ 2
  • Target Mismatch profile: CBF < 30% volume < 100ml, Mismatch volume ≥ 15 ml and Mismatch Ratio >1.
  • Available angiosuite.
  • CBF < 30% volume: 70 - 100 ml when non-contrast computed tomography (NCCT) Alberta Stroke Program Early Computed Tomography Scores (ASPECTS) was 3 - 5 and/or beyond 6 hours after symptom onset

排除标准

  • Evidence of intracranial tumors, the encephalitis, the hemorrhage: either an intracranial hemorrhage (ICH) or subarachnoid hemorrhage (SAH) by the biplane flat panel detector computed tomography.
  • Participated in another studies.
  • Loss to follow-up after discharge.
  • A severe or fatal combined illness before acute stroke.

结局指标

主要结局

Door-to-reperfusion times

时间窗: 1 day (During intrahospital)

Door-to-reperfusion times was defined as the time from admission in emergency department to recanalization in case of large vessel occlusion at the angiosuite..

Functional 3 - month outcome rate

时间窗: 3 months after procedure

Functional 3 - month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).

次要结局

未报告次要终点

研究者

发起方
Can Tho Stroke International Services Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Cuong Tran Chi

Principal Investigator

Can Tho Stroke International Services Hospital

研究点 (2)

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