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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name