UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024571
Receipt number 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 09:47:33

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027844