UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016404 |
|---|---|
| Receipt number | 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 09:17:06 |
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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
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
iwata-m@umin.ac.jp
Sponsor or person
Institute
Hirosaki Stroke and Rehabilitation Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019053
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
