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

Cerebral Arterial Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914288
• Other study ID #: ICD_02
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2016
• Last updated: September 22, 2016
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Asan Medical Center
• Contact: Seung Chai Jung, MD., PhD.
• Phone: 82-2-3010-4355
• Email: dynamics79[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• High 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Bracco Corporate, Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No