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

NCT02914288 | Unknown DMC

• 1 other identifier: ICD_02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

High resolution magnetic resonance imaging for intracranial vessel walls OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute intracranial artery dissection

You may qualify if:

• informed consent
• acute intracranial artery dissection

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Ministry of Health & Welfare, Korea: collaborator
• Bracco Corporate: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Arterial Diseases

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Seung Chai Jung, MD.,PhD.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Chai Jung, MD., PhD.

CONTACT

82-2-3010-4355; dynamics79@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 26, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

KR (1)