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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02914288
Enrollment
20
Registered
2016-09-26
Start date
2016-04-30
Completion date
2018-12-31
Last updated
2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Arterial Diseases, Dissecting Aneurysm of Cerebral Artery, Intimal Dissection

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.

Interventions

OTHERHigh resolution magnetic resonance imaging for intracranial vessel walls

High resolution magnetic resonance imaging for intracranial vessel walls at initial (optional), 1 month, 3 month, 6 month (optional), and 12 month

Sponsors

Ministry of Health & Welfare, Korea
CollaboratorOTHER_GOV
Bracco Corporate
CollaboratorINDUSTRY
Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* informed consent * acute intracranial artery dissection

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

Design outcomes

Primary

MeasureTime frameDescription
Five proportions (%) of dissection findings12 monthsVisual 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 segment12 monthsOuter 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 segment12 monthsWall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area
Remodeling index of dissecting arterial segment and contralateral segment12 monthsRemodeling index= outer wall area of dissection segment / \[(outer wall area of proximal normal looking segment + outer wall area of distal normal looking segment)/2\]
Extent (mm) of dissecting arterial segment and contralateral segment12 monthsLength (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J

Countries

South Korea

Contacts

Primary ContactSeung Chai Jung, MD., PhD.
dynamics79@gmail.com82-2-3010-4355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026