Prospective Observation for Serial Changes in Acute Intracranial Artery Dissection Using HR-MRI

NCT ID: NCT03213470

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-07

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

Conditions

Cerebral Arteries; Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intracranial artery dissection

Patients with intracranial artery dissection who were diagnosed based on the clinical and radiological (including MRI) diagnoses at the symptom onset after Jan-01-2016

Group Type: OTHER

magnetic resonance imaging

Intervention Type: OTHER

Interventions

magnetic resonance imaging

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role: collaborator

Bracco Corporate

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seung Chai Jung

MD. PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung Chai Jung, Professor

Role: PRINCIPAL_INVESTIGATOR

Associate professor, Department of Radiology

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Park KJ, Jung SC, Kim HS, Choi CG, Kim SJ, Lee DH, Suh DC, Kwon SU, Kang DW, Kim JS. Multi-Contrast High-Resolution Magnetic Resonance Findings of Spontaneous and Unruptured Intracranial Vertebral Artery Dissection: Qualitative and Quantitative Analysis According to Stages. Cerebrovasc Dis. 2016;42(1-2):23-31. doi: 10.1159/000444315. Epub 2016 Mar 8.

Reference Type: RESULT

PMID: 26950228 (View on PubMed)

Jeong SY, Jung SC, Roh YH, Kwon SU, Kang DW, Kim JS, Choi KM, Kim S, Jeong E. Serial changes and optimal imaging windows in vessel wall MRI for unruptured intracranial artery dissection. Sci Rep. 2025 Jul 1;15(1):21864. doi: 10.1038/s41598-025-05732-4.

Reference Type: DERIVED

PMID: 40596300 (View on PubMed)

Other Identifiers

ICD_01

Identifier Type: -

Identifier Source: org_study_id