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临床试验/NCT06213870
NCT06213870已完成不适用

Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke

Tianjin Huanhu Hospital1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
1
主要终点
90-day functional independence rate

研究概览

简要总结

The goal of this observational study is to learn about the role of MRI evaluation based on FVH-DWI mismatch principle in preoperative evaluation of endovascular thrombolectomy.

The main questions it aims to answer are:

  • The consistency between MRI and perfusion examination in determining EVT indications.
  • The consistency of functional independence rate between patients screening with MRI and perfusion.

详细描述

MRI is the preferred imaging mode in many centers,for the diffusion-weighted imaging (DWI) sequences are highly sensitive to acute cerebral ischemia.In addition, MRI does not require intravenous contrast agent, which is simpler and more popular than perfusion.Fluid-attenuated inversion recovery (FLAIR)sequence vascular hyperintensity(FVH) is defined as focal, serpentine, or linear hyperintensity that usually occurs in the Sylvian fissure and is associated with large-vessel occlusion or stenosis.The FVH-DWI mismatch(defined as the FVH extended beyond the boundary of the DWI cortical lesions) had been confirmed has excellent sensitivity and specificity in predicting PWI-DWI mismatch.It is not well established whether MRI based on FVH-DWI mismatch and perfusion evaluation differ in determining EVT indications and outcomes.

The main objectives of this study were to (1) determine the proportion of patients eligible for EVT surgery selected by MRI based on FVH-DWI mismatch vs perfusion in a large multicenter registry and (2) identify statistical differences in functional outcomes and safety outcomes between the two evaluation methods.

Patients with ischemic stroke with anterior-circulation large-vessel occlusion in the late (6-24 h) time window from real-world, single center retrospective cohort registry were compared.In the MRI group, patients with FVH-DWI mismatch underwent EVT surgery or were otherwise treated with medication.In the perfusion group, surgical indications referring the DEFUSE 3 standards. The primary outcome was 90-day functional independence rate (mRS score ≤2) in all patients included(including EVT patient and medication patients).Safety outcomes included symptomatic intracranial hemorrhage (sICH), and 90-day mortality.

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

  • (1) age ≥ 18 years old;
  • (2) symptoms consistent with acute ischemic stroke and an onset time of 6-24h;
  • (3) CT ASPECTS score≥6 points;NIHSS≥6points; modified Rankin scale (mRS) of 0-2 points prior to stroke;
  • (4) internal carotid artery (ICA) and/or M1 segment of middle cerebral artery (MCA-M1) and M2 proximal segment occlusion with definite diagnosis.
  • (5)agree to comply with the protocol follow-up requirements.

排除标准

  • (1)Image unanalyzable.
  • (2)3 months follow-up was not completed

结局指标

主要结局

90-day functional independence rate

时间窗: 90days

Proportion of patients with mRS0-2 scores at 90 days

次要结局

  • symptomatic intracranial hemorrhage(90days)

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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