UMIN-CTR Clinical Trial

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
Email	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
Email	skuroda@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045798