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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035081
Receipt No. R000039995
Official scientific title of the study Quantitative blood-brain barrier permeability and susceptibility mapping for patients with CADASIL and suspected to have CADASIL
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/30

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Basic information
Official scientific title of the study Quantitative blood-brain barrier permeability and susceptibility mapping for patients with CADASIL and suspected to have CADASIL
Title of the study (Brief title) BBB permeability and QSM for CADASIL
Region
Japan

Condition
Condition CADASIL
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To quantify blood-brain barrier permeability and susceptibility value in patients with CADASIL, using MRI.
Basic objectives2 Others
Basic objectives -Others To compare the values with non-CADASIL patients
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Quantification of blood-brain barrier permeability and susceptibility value in patients with CADASIL
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are diagnosed with CADASIL and their family
Key exclusion criteria Patients who are prohibited to take MRI
Target sample size 40

Research contact person
Name of lead principal investigator Yuto Uchida
Organization Nagoya city university
Division name Neurology
Address 1 Kawasumi, Mizuho-ku, Nagoya
TEL 0528538094
Email uchidayuto0720@yahoo.co.jp

Public contact
Name of contact person Yuto Uchida
Organization Nagoya City University
Division name Neurology
Address 1 Kawasumi, Mizuho-ku, Nagoya
TEL 0528538094
Homepage URL
Email uchidayuto0720@yahoo.co.jp

Sponsor
Institute Nagoya City University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Cross-sectional/longitudinal observational study

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039995

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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