NCT03213470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

3.3 years

First QC Date

July 7, 2017

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI

    Radiological findings of HR-MRI during the study period

    The time interval from initial event to outcome measurement is 1 year.

Study Arms (1)

Intracranial artery dissection

OTHER

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

Other: magnetic resonance imaging

Interventions

Intracranial artery dissection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Seung Chai Jung, Professor

    Associate professor, Department of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

January 1, 2016

Primary Completion

April 7, 2019

Study Completion

April 7, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations