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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02074111
Other study ID # 2013-08-098-003
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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