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

• Conditions: Cerebral Arterial Diseases; Dissecting Aneurysm of Cerebral Artery; Intimal Dissection

• Registration Number: NCT02914288
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-26
• Last Update Posted: 2016-09-26
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• informed consent
• acute intracranial artery dissection

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent (mm) of dissecting arterial segment and contralateral segment	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	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	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	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	12 months	Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of