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临床试验/NCT04105257
NCT04105257已完成不适用

Evaluation of Diagnostic Performance of Cerebral Perfusion Scans in Pseudo-Stroke: Exploratory Study of Diagnostic Performance

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年10月20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
7
试验地点
2
主要终点
Sensibility

研究概览

简要总结

When a patient is received with the context of acute stroke, they undergo a fast neurological evaluation and obtain a basic appraisal composed of a non-contrast endovascular cerebral scan and an angiography scan of intracranial blood vessels and the neck. Once the structural lesion (hemorrhage, tumor, etc.) is absent, signs of early infracts and confirmed acute intracranial arterial occlusion, the possibility of a pseudo-stroke dwells in the differential diagnostic.

Certain characteristics of history and clinical evaluation create sufficient doubt to evoke the possibility of a pseudo-stroke. In fact, this population is mostly female and the cardiovascular risk factors are less prevalent in this group than for the group of stroke victims. It is on average the youngest and presents a less severe deficit. For the rest, medical antecedents often help to evoke a diagnosis of pseudo-stroke.

详细描述

With this study, the investigators wish to evaluate the diagnostic value of two additional radiological examinations:

  1. Computed tomography perfusion (CTP) imaging to evaluate blood flow in the brain;
  2. Imaging by magnetic resonance (MRI) of the brain to detect lesions from a cerebral vascular accident (stroke) not visible on standard imaging of the brain.

The proposed additional examinations (CTP and MRI) are tests that are currently used at the CHUM. Those are not experimental tests. These tests are commonly used when doctors wants a further investigation to clarify the cause of the neurological symptoms. These tests are usually done in a semi-urgent or non-urgent situations. In the present study they will be done urgently. The investigators wish to determine if obtaining these additional tests in emergency will change the decision of whether to administer the drug (thrombolysis). The investigators want to determine whether one imaging test is sufficient or if both exams are needed to help clinical decision-making. Please note that urgent access to perfusion CT and brain MRI is not considered routine care, since the value of these additional tests has yet to be demonstrated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Admission at CHUM for acute neurological deficit <4,5h (since the onset of symptoms)
  • Potential candidate for an intravenous thrombolysis
  • Cerebral angioscan performed at CHUM at the time of admission
  • Age ≥ 18 years
  • Observed period from September 2019 à June 2020

排除标准

  • Contraindication to intravenous thrombolysis according to the doctor in charge of treatment;
  • Indication of a thrombectomy;
  • Incomplete exam or exam of insufficient technical quality for a reliable radiological interpretation;
  • Contraindication against MRI .

结局指标

主要结局

Sensibility

时间窗: : Immediately after the procedure (CTP scan/MRI)

proportion of patients that are correctly identified as having a pseudo-stroke

Specificity

时间窗: Immediately after the procedure (CTP scan/MRI)

proportion of patient that are correctly identified as not having a pseudo-stroke

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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