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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016404
Receipt No. R000019053
Scientific Title Prevalence of Fabry disease in patients with stroke
Date of disclosure of the study information 2015/02/01
Last modified on 2020/08/05

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Basic information
Public title Prevalence of Fabry disease in patients with stroke
Acronym Fabry stroke screening study
Scientific Title Prevalence of Fabry disease in patients with stroke
Scientific Title:Acronym Fabry stroke screening study
Region
Japan

Condition
Condition Fabry disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to investigate the prevalence of Fabry disease in patients with stroke.
Basic objectives2 Others
Basic objectives -Others Evaluation of globotriaosylsphingosine (Lyso-Gb3) measurement for Fabry disease
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Plasma globotriaosylsphingosine (Lyso-Gb3)
Key secondary outcomes Plasma enzymatic activity of alpha-galactsidase

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We take blood sample of 2ml for the patients.
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

Not applicable
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria Cerebral infarction
Cerebral hemorrhage
Key exclusion criteria Cardioembolic
Subarachnoid hemorrhage
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Iwata
Organization Hirosaki Stroke and Rehabilitation Center
Division name Department of Rehabilitation
Zip code 036-8104
Address 1-2-1,Ougimachi,Hirosaki City,Aomori
TEL 0172-28-8220
Email iwata-m@umin.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Iwata
Organization Hirosaki Stroke and Rehabilitation Center
Division name Department of Rehabilitation
Zip code 036-8104
Address 1-2-1,Ougimachi,Hirosaki City,Aomori
TEL 0172-28-8220
Homepage URL
Email iwata-m@umin.ac.jp

Sponsor
Institute Hirosaki Stroke and Rehabilitation Center
Institute
Department

Funding Source
Organization Genzyme Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hirosaki Stroke and Rehabilitation Center
Address 1-2-1,Ougimachi,Hirosaki City,Aomori
Tel 0172-28-8220
Email f_nara@reimeikyou.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
2015 Year 02 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 Completed
Date of protocol fixation
2014 Year 12 Month 15 Day
Date of IRB
2014 Year 12 Month 15 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 31 Day
Last modified on
2020 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019053

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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