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

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ClinicalTrials.gov Identifier: NCT03213470
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Bracco Corporate
Information provided by (Responsible Party):
Seung Chai Jung, Asan Medical Center

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. We 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 we 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. I'm sure that the longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. In addition, our 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

Condition or disease Intervention/treatment Phase
Cerebral Arteries Dissection Other: magnetic resonance imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 31, 2018

Arm Intervention/treatment
Intracranial artery dissection
Patients with intracranial artery dissection who were diagnosed at the symptom onset after Jan-01-2016
Other: magnetic resonance imaging



Primary Outcome Measures :
  1. Prospective observation for serial changes in acute intracranial artery dissection using HR-MRI [ Time Frame: The time interval from initial event to outcome measurement is 1 year. ]
    Radiological findings of HR-MRI during the study period



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213470


Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung Chai Jung, PhD.    82-2-3010-4355    dynamics79@gmail.com   
Principal Investigator: Seung Chai Jung, PhD.         
Sponsors and Collaborators
Asan Medical Center
Ministry of Health & Welfare, Korea
Bracco Corporate

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Responsible Party: Seung Chai Jung, MD. PhD., Asan Medical Center
ClinicalTrials.gov Identifier: NCT03213470     History of Changes
Other Study ID Numbers: ICD_01
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017