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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Arterial Diseases; Intimal Dissection; Dissecting Aneurysm of Cerebral Artery
• Intervention / Treatment: Other: High resolution magnetic resonance imaging for intracranial vessel walls

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
    • Contact: Seung Chai Jung, PhD.; Phone Number: 82-2-3010-4355; Email: dynamics79@gmail.com
    • Principal Investigator: Seung Chai Jung, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute intracranial artery dissection

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five proportions (%) of dissection findings	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	12 months
Three diameters (mm) of dissecting arterial segment and contralateral segment	Outer diameter, Inner luminal diameter, Normal diameter (mm) by measured semi-automatic in-house analysis software based on Image J	12 months
Wall measurement (mm2) of dissecting arterial segment and contralateral segment	Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area	12 months
Remodeling index of dissecting arterial segment and contralateral segment	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]	12 months
Extent (mm) of dissecting arterial segment and contralateral segment	Length (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J	12 months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Ministry of Health & Welfare, Korea; Bracco Corporate
• Investigators: Principal Investigator: Seung Chai Jung, MD.,PhD., Asan Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 26, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Aneurysm, Dissecting; Cerebral Arterial Diseases
• Other Study ID Numbers: ICD_02