Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03213470
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2017-07-07
Brief Title:
Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using HR-MRI
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using High Resolution Vessel Wall Magnetic Resonance Imaging
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 longitudinal information from this study could guide us as the important map on the confusing HR-MR findings In addition the previous retrospective study can be a stepping-stone to perform a prospective study which can increase the success rate of the prospective study The protocols for imaging follow-up are as followed initial optional 1 month 3 month 6 month optional 12 month
Detailed Description:
Inclusion criteria
1 adults with equal to or greater than 18 year-old
2 confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses
3 informed consent
Exclusion criteria
1 contraindicated for MRI scanning and contrast media usage
2 refuse the enrollment
Outcome measures
1 Serial follow-up with intraindividual comparisons and interstage comparisons
Radiological features intimal flap double lumen aneurysmal dilatation intramural hematoma luminal stenosis contrast enhancement degree diameters length wall thickness eccentricity index
Clinical features mRS NIHSS drug
2 Demographics
1 adults with equal to or greater than 18 year-old
2 confirmed as acute intracranial artery dissection based on the clinical and radiological diagnoses
3 informed consent
Exclusion criteria
1 contraindicated for MRI scanning and contrast media usage
2 refuse the enrollment
Outcome measures
1 Serial follow-up with intraindividual comparisons and interstage comparisons
Radiological features intimal flap double lumen aneurysmal dilatation intramural hematoma luminal stenosis contrast enhancement degree diameters length wall thickness eccentricity index
Clinical features mRS NIHSS drug
2 Demographics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None