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临床试验/NCT03213470
NCT03213470已完成不适用

Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using High Resolution Vessel Wall Magnetic Resonance Imaging

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI

研究概览

简要总结

Intracranial artery disease has been more detected with development of HR-MR. HR-MR can depict vascular wall directly and give us more information beyond the pre-existing imaging modalities such as digital subtraction angiography, magnetic resonance angiography, computed tomography angiography. Hence, HR-MR is considered to become promising imaging modality for intracranial artery disease and many studies have been published recently. However, there was not enough to differentiate various intracranial artery disease such as atherosclerosis, dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real clinical arena, intracranial artery disease is too difficult to diagnose and distinguish among the disease. Of the disease, usefulness of HR-MR has been consistently published in the detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the most important and reliable imaging method in intracranial artery dissection as of now. Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial artery dissection is dynamic vascular pathology. The geometric change is the most common among intracranial artery disease. However, there was no report about the geometric change in HR-MR. The investigators acquired retrospective data about the natural course of intracranial artery dissection in HR-MR and are preparing for publishing an article. However, the data is not prospective and not intraindividual comparison. Therefore, reliability is not enough to convince the natural course. If the investigators got prospective and intraindividual data, definite natural course of intracranial artery dissection could be acquired and would be helpful to diagnose the dissection and differentiate from other vascular pathologies. The longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. In addition, the previous retrospective study can be a stepping-stone to perform a prospective study, which can increase the success rate of the prospective study. The protocols for imaging follow-up are as followed: initial (optional), 1 month, 3 month, 6 month (optional), 12 month

详细描述

Inclusion criteria:

  1. adults with equal to or greater than 18 year-old
  2. confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses
  3. informed consent

Exclusion criteria:

  1. contraindicated for MRI scanning and contrast media usage
  2. refuse the enrollment

Outcome measures

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

性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Acute intracranial artery dissection

排除标准

  • angioplasty, or stenting,
  • contraindication for MR imaging,
  • Hypersensitivity to gadolinium based contrast media,
  • Pregnant or lactating women,
  • Renal condition : eGFR < 60, 6) Patients unable and/or unwilling to comply with treatment or study instructions

结局指标

主要结局

Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI

时间窗: The time interval from initial event to outcome measurement is 1 year.

Radiological findings of HR-MRI during the study period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung Chai Jung

MD. PhD.

Asan Medical Center

研究点 (2)

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