UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006640 |
|---|---|
| Receipt number | R000007854 |
| Scientific Title | Asymptomatic Moyamoya Registry |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2021/12/03 09:26:47 |
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Basic information
Public title
Asymptomatic Moyamoya Registry
Acronym
AMORE
Scientific Title
Asymptomatic Moyamoya Registry
Scientific Title:Acronym
AMORE
Region
| Japan |
Condition
Condition
Moyamoya disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the epidemiology, clinical features, pathophysiology, and prognosis of asymptomatic moyamoya disease.
Basic objectives2
Others
Basic objectives -Others
To explore the epidemiology, clinical features, pathophysiology, and prognosis of asymptomatic moyamoya disease.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of all ischemic or hemorrhagic stroke during 5-year follow-up
Key secondary outcomes
1) Incidence of TIA, silent infarct, disease progression, silent micro bleeds, or death during 5-year follow-up
2) Incidence of further ischemic or hemorrhagic stroke, TIA, silent infarct, disease progression, silent micro bleeds, or death during 5-year follow-up
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 20 to 69 years old
(2) Newly diagnosed as bilateral or unilateral moyamoya disease
(3) no history of TIA or ischemic or hemorrhagic stroke in adulthood
(4) conservatively followed up
(5) modified Rankin scale, 0 or 1
(6) regular follow-up at out-patient clinic
(7) informed consent obtained
Key exclusion criteria
(1) history of TIA or ischemic or hemorrhagic stroke in adulthood
(2) quasi-moamoya disease
(3) contra-indication of MR examination
(4) judged as non-moyamoya disease by Image Analyzing Committee
(5) judged as inappropriate patients by doctor-in-charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
University of Toyama
Division name
Neurosurgery
Zip code
930-0194
Address
2630 Sugitani Toyama
TEL
076-434-7348
skuroda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
Toyama University Hospital
Division name
Neurosurgery
Zip code
930-0194
Address
Sugitani 2630, Toyama, Japan
TEL
076-434-7348
Homepage URL
skuroda@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Research Committee on Moyamoya disease
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani Toyama
Tel
076-434-7348
skuroda@med.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学（北海道）、中村記念病院（北海道）、岩手医科大学（岩手県）、東北大学（宮城県）、東京大学（東京都）、東京女子医科大学（東京都）、東京医科歯科大学（東京都）、千葉循環器病センター（千葉県）、慶応大学（東京都）、北里大学（神奈川県）、名古屋大学（愛知県）、名古屋市立大学（愛知県）、富山大学（富山県）、福井大学（福井県）、京都大学（京都府）、国立循環器病研究センター（大阪府）、大阪大学（大阪府）、岡山大学（岡山県）、九州大学（福岡県）、長崎大学（長崎県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/nmc/55/3/55_ra.2014-0305/_article
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
106
Results
Results date posted
| 2020 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
When the enrolled patients experience primary or secondary outcome, the doctors-in-charge must precisely report it to the Research Committee.
Management information
Registered date
| 2011 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007854
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
