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Recruitment status Completed
Unique ID issued by UMIN UMIN000015159
Receipt No. R000017552
Scientific Title Effects of Fabry disease on the prognosis of cerebrovascular disease
Date of disclosure of the study information 2014/09/15
Last modified on 2016/03/15

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Basic information
Public title Effects of Fabry disease on the prognosis of cerebrovascular disease
Acronym Effects of Fabry disease on the prognosis of cerebrovascular disease
Scientific Title Effects of Fabry disease on the prognosis of cerebrovascular disease
Scientific Title:Acronym Effects of Fabry disease on the prognosis of cerebrovascular disease
Region
Japan

Condition
Condition cerebrovascular disease
Classification by specialty
Medicine in general Cardiology Nephrology
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To know the effects of Fabry disease on the prognosis of cerebravascular disease.
Basic objectives2 Others
Basic objectives -Others To know the effects of Fabry disease on the prognosis of cerebravascular disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NIHSS, recurrenca, Heart function, Reanal function.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria None
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Johkura
Organization Yokohama Stroke and Brain Center
Division name Neurology
Zip code
Address 1-2-1 Takigashira, Isogo-ku, Yokohama city, Knagawa, Japan
TEL 045-753-2500
Email ke00-johkura@city.yokohama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoko Imazeki
Organization Yokohama Stroke and Brain Center
Division name Neurology
Zip code
Address 1-2-1 Takigashira, Isogo-ku, Yokohama city, Knagawa, Japan
TEL 045-753-2500
Homepage URL
Email Kisaragi1967@aol.com

Sponsor
Institute Yokohama Stroke and Brain Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Yokohama Stroke and Brain Center
Organization
Division
Category of Funding Organization Local Government
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
2014 Year 09 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 Completed
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 09 Day
Last follow-up date
2016 Year 01 Month 15 Day
Date of closure to data entry
2016 Year 01 Month 15 Day
Date trial data considered complete
2016 Year 01 Month 15 Day
Date analysis concluded
2016 Year 04 Month 30 Day

Other
Other related information NIHSS, recurrenca, Heart function, Reanal function.

Management information
Registered date
2014 Year 09 Month 15 Day
Last modified on
2016 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017552


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