UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044293 |
|---|---|
| Receipt number | R000050593 |
| Scientific Title | Multicenter survey of moyamoya disease over the age of sixty |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/05/22 12:51:41 |
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Basic information
Public title
Multicenter survey of moyamoya disease over the age of sixty
Acronym
MODEST
Scientific Title
Multicenter survey of moyamoya disease over the age of sixty
Scientific Title:Acronym
MODEST
Region
| Japan |
Condition
Condition
Moyamoya disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the epidemiology, pathophysiology and prognosis of moyamoya disease over 60 years old
Basic objectives2
Others
Basic objectives -Others
epidemiology, pathophysiology and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any cerebral infarction and intracranial hemorrhage in 5 years after inclusion
Key secondary outcomes
1) Occurrence rate of the following for 5 years
1 transient ischemic attack
2 asymptomatic cerebral infarction
3 progression of the stage
4 asymptomatic hemorrhage
5 death
2) Preoperative complication
1 cerebral infarction (ipsilateral to surgery)
2 hyperperfusion syndrome
3 Decrease of ADL after surgical complication
3) Any stroke 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
1) Patients aged 60 years or older
2) Patients with a neuroradiological diagnosis of moyamoya disease
3) Patients who can go to an outpatient clinic and follow up
4) Patients who have given consent to participate in the study
Key exclusion criteria
Exclusion criteria
1) Patients with quasi-moyamoya disease
2) Patients who cannot undergo MRI
3) Patients who is not diagnosed as moyamoya disease by the Image Judgment Committee
4) Patients who are judged to be ineligible by the research comittee
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Teiji |
| Middle name | |
| Last name | Tominaga |
Organization
Tohoku University, Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7230
tomi@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Endo |
Organization
Kohnan Hospital
Division name
Department of Neurosurgery
Zip code
982-8523
Address
4-20-1, Nagamachi-minami, Taihaku-ku, Sendai
TEL
022-248-2131
Homepage URL
h-endo@nsg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour 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
Tohoku University IRB
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-718-0461
office@nrs.hosp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection of image data and outcomes at registration, 1 year, 2 years, 3 years, 4 years, and 5 years.
Management information
Registered date
| 2021 | Year | 05 | Month | 22 | Day |
Last modified on
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050593
| 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 |
