Moyamoya Disease Biomarkers in Patients With Intracranial... | NCT02074111

Studies
Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

NCT02074111

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 26, 2017Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Moyamoya Disease
Intracranial Atherosclerotic Stroke
Intracranial Steno-occlusive Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 26, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2017

Last Update Posted Date

Apr 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).
Conditions: Stroke, intracranial occlusive lesion
Intervention: None
Study period: Jan 22, 2014 ~ Dec 31, 2016
Study design: Observational model Time perspective: Retrospective-Prospective

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)
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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Tertiary Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oh Young Bang, MD PhD	Contact	82-2-3410-3599		nmboy@unitel.co.kr

Overall Officials

Name	Affiliation	Role
Oh Young Bang, MD PhD	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36367058	Derived	Kim JY, Kim HJ, Choi EH, Pan KH, Chung JW, Seo WK, Kim GM, Jee TK, Yeon JY, Kim JS, Hong SC, Seong MJ, Cha J, Kim KH, Jeon P, Bang OY. Vessel Wall Changes on Serial High-Resolution MRI and the Use of Cilostazol in Patients With Adult-Onset Moyamoya Disease. J Clin Neurol. 2022 Nov;18(6):610-618. doi: 10.3988/jcn.2022.18.6.610.

ID	Term
D009072	Moyamoya Disease
C536992	Moyamoya disease 2

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Label	Type	Description	Intervention Names
Intracranial atherosclerotic stroke
Moyamoya disease
Healthy controls