Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

• Conditions: Intracranial Steno-occlusive Disease; Moyamoya Disease; Intracranial Atherosclerotic Stroke

• Registration Number: NCT02074111
• Lead Sponsor: Samsung Medical Center

Brief Summary

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).

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of RNF213 gene variants and HR-MRI findings in patients with intracranial atherosclerosis	Anytime during study period (in intracranial atherosclerosis, HR-MRI findings within 2 weeks)

Secondary Outcome Measures

Name	Time	Method
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	Within 2 years

Trial Locations

Locations (1)

Department of Neurology, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of