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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024571
Receipt No. R000027844
Scientific Title A MRI study in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) at 7T
Date of disclosure of the study information 2016/11/01
Last modified on 2017/10/27

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Basic information
Public title A MRI study in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) at 7T
Acronym A MRI study in CADASIL at 7T
Scientific Title A MRI study in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) at 7T
Scientific Title:Acronym A MRI study in CADASIL at 7T
Region
Japan

Condition
Condition CADASIL
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of the study is to clarify the mechanism of desease develpment through in-vivo observation of the patient brain.
Basic objectives2 Others
Basic objectives -Others Acquire 7T MRI dataset of brain images from patient and healthy control groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NA
Key secondary outcomes

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
10 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Registered in the CADASIL database
Key exclusion criteria Those not suitable for MRI
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Aso
Organization Kyoto University Graduate School of Medicine
Division name Human Brain Research Center
Zip code
Address Shogoin-kawaharacho 54
TEL 0757513695
Email toaso@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Aso
Organization Kyoto University Graduate School of Medicine
Division name Human Brain Research Center
Zip code
Address Shogoin-kawaharacho 54
TEL 0757513695
Homepage URL
Email toaso@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 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
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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2016 Year 10 Month 26 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027844

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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