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临床试验/NCT02914288
NCT02914288Unknown不适用

Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Extent (mm) of dissecting arterial segment and contralateral segment

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 prospective longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month (optional), 12 month.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

Extent (mm) of dissecting arterial segment and contralateral segment

时间窗: 12 months

Length (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J

Remodeling index of dissecting arterial segment and contralateral segment

时间窗: 12 months

Remodeling index= outer wall area of dissection segment / \[(outer wall area of proximal normal looking segment + outer wall area of distal normal looking segment)/2\]

Five proportions (%) of dissection findings

时间窗: 12 months

Visual detection based on PACS system by obsevers: Presence or absence of each finding (intimal flap, double lumen, intramural hematoma, aneursymal dilatation, wall enhancement): Proportions (%)= number of patients with presence of each finding/ number of all patients

Three diameters (mm) of dissecting arterial segment and contralateral segment

时间窗: 12 months

Outer diameter, Inner luminal diameter, Normal diameter (mm) by measured semi-automatic in-house analysis software based on Image J

Wall measurement (mm2) of dissecting arterial segment and contralateral segment

时间窗: 12 months

Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area

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 (1)

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