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临床试验/NCT05885178
NCT05885178Enrolling By Invitation不适用

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1): an Imaging-based Patient Registry Study

Tianjin Huanhu Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年1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
5,000
试验地点
1
主要终点
Modified ranking scale (mRS) at 90 days

研究概览

简要总结

The aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (AIS) due to large vessel occlusions (LVO), treated with either endovascular therapy (EVT) or best medical management (BMM).

详细描述

Stroke is a major threat to public health and is exacerbating socioeconomic development. It is the leading cause of mortality among residents in China. Large vessel occlusion (LVO) is a predictor of unfavorable outcomes and can account for up to 52% of patients with acute ischemic stroke (AIS). The definition of LVO and its optimal screening imaging modalities remain controversial. In this registry, the investigators defined LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA.

TRACK-LVO is an academic, real-world, single-center, observational registry, in which consecutive patients hospitalized with AIS due to LVO will be treated with either EVT or BMM. Baseline information and clinical follow-up information at 90 days from stroke onset are collected. The key baseline items in this registration for both EVT and BMM groups include basic demographic profiles, past medical history, NIHSS score, treatment with intravenous alteplase, type of stroke onset, time from stroke onset to admission/imaging, imaging characteristics such as the volume of the ischemic core and occlusion site, and treatment-related complications. Additional information collected in EVT groups includes details of EVT procedure and angiographic images.

The investigators enrolled patients with LVO screened under different imaging modalities to further reveal the optimal imaging modalities in the detection of LVO. The investigators also tend to compare the prognosis of AIS patients with LVO receiving endovascular therapy and the best medical management respectively.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;
  • Ischemic stroke confirmed by head CT or MRI;
  • Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
  • Patients receiving either endovascular therapy or best medical treatment;

排除标准

  • 未提供

结局指标

主要结局

Modified ranking scale (mRS) at 90 days

时间窗: 90 days

A 0-6 scale running from perfect health without symptoms to death.

Mortality within 90 days

时间窗: 90 days

mortality of any causes.

次要结局

  • National Institutes of Health Stroke Scale (NIHSS) scores at 90 days(90 days)
  • Occurrence of periprocedural complications(14 days postoperatively)
  • ASPECT score (Alberta Stroke Program Early CT score)(Day 0)

研究者

发起方
Tianjin Huanhu Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming Wei

Chief Physician

Tianjin Huanhu Hospital

研究点 (1)

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