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临床试验/NCT04651010
NCT04651010招募中不适用

Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Correlation between modified Rankin score at 3 months and multimodal MRI data

研究概览

简要总结

Our study aims to measure metabolic and functional parameters of the infarcted territory by multimodal cerebral MRI in patients diagnosed with unilateral proximal occlusion of the middle cerebral artery and treated by thrombectomy in order to correlate those parameters to clinical outcome (evaluated by modified Rankin score) at 3 months.

We aim to find early radiologic predictive factors for favorable clinical outcome in this population of patients.

详细描述

The treatment of acute ischemic stroke in the setting of intracranial large artery occlusion and especially middle cerebral artery occlusion (MCAO) with intravenous tissue plasminogen activator (IV-tPA) is associated with low rates of recanalization and high rates of neurological morbidity and functional dependence.

In the last few years, endovascular intervention (mechanical thrombectomy) has proven its safety and its efficacy on clinical outcome in patients diagnosed with MCAO and is now commonly recommended.

However, in this population of patients treated by thrombectomy, very few predictive factors, except for the post-procedural recanalization score (TICI), do exist to foresee the variability of clinical outcome.

Tissue viability of the infarcted territory can be approached by the measure of metabolic and morphological parameters (Na+, H+, phosphore, diffusion imaging) which can be non-invasively done by multimodal MRI, as suggest by recently published studies.

Our study plans to measure these parameters between 12 and 24 hours after acute ischemic stroke in patients with MCAO treated by thrombectomy in order to correlate those parameters to clinical outcome at 3 months (modifier Rankin Score).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged ≥ 18 years old
  • •Hospitalized at the Poitiers University Hospital
  • •Acute middle cerebral artery occlusion diagnosed by CT-scan or MRI
  • •NIHSS score ≥ 6 at admission
  • •To be treated by thrombectomy with or without fibrinolysis
  • •Written information delivered to the patient or his relatives concerning the study and its benefit and risk

排除标准

  • •Patients or relatives whom a loyal information about the study cannot be given
  • •Patient with cognitive impairments before MRI.
  • •Patients who cannot undergo MRI because of contraindications
  • •Patients too deteriorated to tolerate one hour long exam

研究组 & 干预措施

Multimodal MRI

Experimental

干预措施: Multimodal MRI (Other)

结局指标

主要结局

Correlation between modified Rankin score at 3 months and multimodal MRI data

时间窗: Month 3

次要结局

  • Change in NIHSS score at 3 months compared to post-thrombectomy(Month 3)
  • Discharge National Institute of Health Stroke Score (NIHSS)(Month 3)
  • National Institute of Health Stroke (NIHSS) score at 3 months(Month 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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