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Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

This study is currently recruiting participants.
Verified April 2017 by Oh Young Bang, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02074111
First Posted: February 28, 2014
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Oh Young Bang, Samsung Medical Center
  Purpose
The aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients).

Condition
Moyamoya Disease Intracranial Atherosclerotic Stroke Intracranial Steno-occlusive Disease

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Other
Official Title: Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

Resource links provided by NLM:


Further study details as provided by Oh Young Bang, Samsung Medical Center:

Primary Outcome Measures:
  • Frequency of RNF213 gene variants and HR-MRI findings in patients with intracranial atherosclerosis [ Time Frame: Anytime during study period (in intracranial atherosclerosis, HR-MRI findings within 2 weeks) ]

Secondary Outcome Measures:
  • Frequency of typical angiographic findings of moyamoya disease at follow up conventional angiography in patients with intracranial atherosclerosis who showed typical gene and imaging biomarkers of moyamoya disease [ Time Frame: Within 2 years ]

Biospecimen Retention:   Samples With DNA
Blood sample

Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intracranial atherosclerotic stroke
Moyamoya disease
Healthy controls

Detailed Description:
  1. Purpose Both moyamoya disease (MMD) and intracranial atherosclerotic stenosis (ICAS) are more prevalent in Asians than in Westerners, although the reason for the race-ethnic differences is unsettled. It is possible that patients with adult-onset MMD were misclassified as having ICAS, which may in part explain the high prevalence of intracranial atherosclerosis in Asians. It is important to differentiation between these two diseases because MMD and ICAS have differential therapeutic strategies (surgical revascularization in MMD vs. the use of antithrombotics/statins and stenting in ICAS). The ring finger 213 (RNF213) was recently identified as a susceptibility gene for MMD in East Asians. Characteristic high-resolution (HR) MRI findings of MMD and ICAS have recently been reported. The aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients).
  2. Conditions: Stroke, intracranial occlusive lesion
  3. Intervention: None
  4. Study period: Jan 22, 2014 ~ Dec 31, 2016
  5. Study design: Observational model Time perspective: Retrospective-Prospective
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Tertiary Hospital
Criteria

Inclusion Criteria:

  1. Intracranial atherosclerotic stroke

    • Patients with age over 20 years
    • Patients with focal neurological deficits presented within 7 days of symptom onset
    • Patients with acute ischemic lesions on diffusion-weighted image (DWI)
    • Patients with stenosis on the relevant intracranial vessels (distal ICA and/ or M1)
  2. Moyamoya disease

    • Patients with age over 20 years
    • Patients who performed conventional angiography
    • Patients who are diagnosed as having either definite or probable Moyamoya disease
  3. Healthy subjects

    • Subjects with age over 20 years
    • Subjects with no history of cerebrovascular disease

Exclusion Criteria:

  • Patients with extracranial stenosis more than 50%
  • Patients with potential sources of cardio-aortic embolism
  • Patients with moderate to severe renal disease
  • Pregnancy or lactation
  • Patients with short life expectancy
  Contacts and Locations
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): NCT02074111


Contacts
Contact: Oh Young Bang, MD PhD 82-2-3410-3599 nmboy@unitel.co.kr

Locations
Korea, Republic of
Department of Neurology, Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Oh Young Bang, MD PhD    82-2-3410-3599    nmboy@unitel.co.kr   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Oh Young Bang, MD PhD Associate Professor
  More Information

Responsible Party: Oh Young Bang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02074111     History of Changes
Other Study ID Numbers: 2013-08-098-003
First Submitted: February 26, 2014
First Posted: February 28, 2014
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Oh Young Bang, Samsung Medical Center:
Moyamoya disease
Intracranial atherosclerotic stroke
Intracranial steno-occlusive disease
ring finger 213 (RNF213) gene mutation
high-resolution MRI

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Stroke
Moyamoya Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases