Moyamoya DiseaseNCT02074111
Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke
An observational study of Moyamoya Disease and Intracranial Atherosclerotic Stroke, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease, Intracranial Atherosclerotic Stroke, Intracranial Steno-occlusive Disease
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary Hospital
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology, Samsung Medical Center
Seoul, 135-710
Oh Young Bang, MD PhD, 82-2-3410-3599, nmboy@unitel.co.kr
About this study
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).
Read the 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
- Conditions
- Moyamoya Disease, Intracranial Atherosclerotic Stroke, Intracranial Steno-occlusive Disease
- Keywords
- Moyamoya disease, Intracranial atherosclerotic stroke, Intracranial steno-occlusive disease, ring finger 213 (RNF213) gene mutation, high-resolution MRI
- Medical subject headings
- Moyamoya Disease, Moyamoya disease 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial atherosclerotic stroke | Not described | |
| Moyamoya disease | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of RNF213 gene variants and HR-MRI findings in patients with intracranial atherosclerosis
Measured: Anytime during study period (in intracranial atherosclerosis, HR-MRI findings within 2 weeks)
Secondary outcomes (1)
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
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oh Young Bang, Samsung Medical Center
- Investigators
- Oh Young Bang, MD PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074111
- Sponsor's protocol ID
- 2013-08-098-003
- Status last verified
- Apr 2017
- First submitted
- 26 Feb 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36367058
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke
- ClinicalTrials.gov ID
- NCT02074111
- Acronym / sponsor ID
- 2013-08-098-003
- Conditions
- Moyamoya Disease, Intracranial Atherosclerotic Stroke, Intracranial Steno-occlusive Disease
- Keywords
- Moyamoya disease, Intracranial atherosclerotic stroke, Intracranial steno-occlusive disease, ring finger 213 (RNF213) gene mutation, high-resolution MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracranial atherosclerotic stroke | – | – |
| Moyamoya disease | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Hospital
Key inclusion criteria (12 listed)
- Intracranial atherosclerotic stroke
- Moyamoya disease
- Healthy subjects
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 36367058Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Young Bang, MD PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease and Intracranial Atherosclerotic Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh Young Bang, MD PhD (82-2-3410-3599, nmboy@unitel.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.