Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

Moyamoya Disease Clinical Trial

Official title:

Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02074111
• Other study ID #: 2013-08-098-003
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2014
• Last updated: April 24, 2017
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Oh Young Bang, MD PhD
• Phone: 82-2-3410-3599
• Email: nmboy[@]unitel.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Atherosclerotic Stroke
• Intracranial Steno-occlusive Disease
• Moyamoya Disease
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurology, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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