Clinical trial NCT02914288: Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI
Official title: Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Arterial Diseases
Dissecting Aneurysm of Cerebral Artery
Intimal Dissection
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Bracco Corporate
First posted: 2016-09-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute intracranial artery 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.


Eligibility criteria: 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

Primary outcomes:
measure: Five proportions (%) of dissection findings
timeFrame: 12 months
measure: Three diameters (mm) of dissecting arterial segment and contralateral segment
timeFrame: 12 months
measure: Wall measurement (mm2) of dissecting arterial segment and contralateral segment
timeFrame: 12 months
measure: Remodeling index of dissecting arterial segment and contralateral segment
timeFrame: 12 months
measure: Extent (mm) of dissecting arterial segment and contralateral segment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seung Chai Jung, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: