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

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ClinicalTrials.gov Identifier: NCT02914288
Recruitment Status : Unknown
Verified September 2016 by Seung Chai Jung, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
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. 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.

Condition or disease Intervention/treatment
Cerebral Arterial Diseases Dissecting Aneurysm of Cerebral Artery Intimal Dissection Other: High resolution magnetic resonance imaging for intracranial vessel walls

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018



Intervention Details:
  • Other: High 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


Primary Outcome Measures :
  1. Five proportions (%) of dissection findings [ Time Frame: 12 months ]
    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

  2. Three diameters (mm) of dissecting arterial segment and contralateral segment [ Time Frame: 12 months ]
    Outer diameter, Inner luminal diameter, Normal diameter (mm) by measured semi-automatic in-house analysis software based on Image J

  3. Wall measurement (mm2) of dissecting arterial segment and contralateral segment [ Time Frame: 12 months ]
    Wall area by measured semi-automatic in-house analysis software based on Image J: Wall area (mm2)= Outer wall area - luminal area

  4. Remodeling index of dissecting arterial segment and contralateral segment [ Time Frame: 12 months ]
    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]

  5. Extent (mm) of dissecting arterial segment and contralateral segment [ Time Frame: 12 months ]
    Length (mm) on curved multiplanar reconstructed images by measured semi-automatic in-house analysis software based on Image J



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute intracranial artery dissection
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): NCT02914288


Contacts
Contact: Seung Chai Jung, MD., PhD. 82-2-3010-4355 dynamics79@gmail.com

Locations
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
Investigators
Principal Investigator: Seung Chai Jung, MD.,PhD. Asan Medical Center

Responsible Party: Seung Chai Jung, MD. PhD., Asan Medical Center
ClinicalTrials.gov Identifier: NCT02914288     History of Changes
Other Study ID Numbers: ICD_02
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Aneurysm
Aneurysm, Dissecting
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs