UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040169 |
|---|---|
| Receipt number | R000045798 |
| Scientific Title | Moyamoya Disease with Aggressive Clinical Course in Infants for Safety and Healthy Growth Study |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2021/12/03 09:28:58 |
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Basic information
Public title
Moyamoya Disease with Aggressive Clinical Course in Infants for Safety and Healthy Growth Study
Acronym
MACINTOSH Study
Scientific Title
Moyamoya Disease with Aggressive Clinical Course in Infants for Safety and Healthy Growth Study
Scientific Title:Acronym
MACINTOSH Study
Region
| Japan |
Condition
Condition
moyamoya disease
Classification by specialty
| Neurosurgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to collect clinical data on neonatal or infantile moyamoya disease from the participants and to clarify its pathophysiology, diagnosis, and treatment in this rare disease entity.
Basic objectives2
Others
Basic objectives -Others
This study is aimed to collect clinical data on neonatal or infantile moyamoya disease from the participants and to clarify its pathophysiology, diagnosis, and treatment in this rare disease entity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of following events in infantile moyamoya disease (<4 years old)
1) stroke before bypass surgery
2) disease progression
3) perioperative complications
4) repeat bypass for ACA/PCA area
5) any death
6) poor functional outcome (mRS=3-5)
7) poor intellectual outcome (FSIQ<60)
Key secondary outcomes
Incidence of flooding events in infantile moyamoya disease (<4 years old)
1) anti platelet
2) postoperative anemia
3) disease stage and moyamoya vessels at the onset
4) cerebral infarct at the onset
5) increase of cerebral infarct during follow-up period
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
| Not applicable |
Age-upper limit
| 4 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) younger than 4 years old
2) onset between Jan 2008 and December 2018
3) radiologically confirmed moyamoya disease
4) patients with disease progression, recurrence of cerebrovascular events, or perioperative complications
5) Informed consent was obtained
Key exclusion criteria
1) informed consent was not obtained
2) doctor-in-charge did not accept the enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
+81-76-434-7348
skuroda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
930-0194
Address
2630 Sugitani, Toyama, Japan
TEL
+81-76-434-7348
Homepage URL
skuroda@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani, Toyama, Japan
Tel
+81-76-434-7348
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
北海道大学脳神経外科、東北大学脳神経外科、東京女子医科大学脳神経外科、東京大学脳神経外科、東京女子医科大学八千代医療センター、東京医科歯科大学脳神経外科、京都大学脳神経外科、国立循環器病研究センター脳神経外科、岡山大学脳神経外科、九州大学脳神経外科、名古屋大学脳神経外科、徳島大学脳神経外科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | 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=R000045798
