ClinicalTrials.gg
Status unknownNCT02914288Updated Sep 26, 2016

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

An observational study in Cerebral Arterial Diseases, Dissecting Aneurysm of Cerebral Artery and Intimal Dissection, sponsored by Asan Medical Center. Status unknown at 1 site in South Korea. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by Asan Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Arterial Diseases
  • Dissecting Aneurysm of Cerebral Artery
  • Intimal Dissection
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Acute intracranial artery dissection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • informed consent
  • acute intracranial artery dissection

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • OtherHigh 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

  2. 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

    Time frame: 12 months

  3. 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

    Time frame: 12 months

  4. Remodeling index of dissecting arterial segment and contralateral segment

    Remodeling index= outer wall area of dissection segment / \[(outer wall area of proximal normal looking segment + outer wall area of distal normal looking segment)/2\]

    Time frame: 12 months

  5. 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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Asan Medical Center
    Seoul, Seoul 138-736, South Korea
    • Seung Chai Jung, PhD. · Contact · dynamics79@gmail.com · 82-2-3010-4355
    • Seung Chai Jung, PhD. · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2016
First posted
Sep 26, 2016
Start
Apr 2016
Primary completionEst.
Dec 2017
CompletionEst.
Dec 2018
Last update
Sep 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02914288
Collaborators
Ministry of Health & Welfare, Korea, Bracco Corporate
Responsible party
Seung Chai Jung (MD. PhD., Asan Medical Center) — Principal investigator
First posted
Sep 26, 2016
Start date
Apr 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 26, 2016

Study contacts

Seung Chai Jung, MD., PhD.
Contact
dynamics79@gmail.com
82-2-3010-4355
Seung Chai Jung, MD.,PhD.
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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