UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015593 |
|---|---|
| Receipt number | R000018118 |
| Scientific Title | The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama. |
| Date of disclosure of the study information | 2014/11/04 |
| Last modified on | 2018/05/07 09:44:41 |
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Basic information
Public title
The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Acronym
The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Scientific Title
The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Scientific Title:Acronym
The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the prevalence of Fabry disease in patients with a diagnosis of HCM (LVH more than 11mm), had examinations of ecocardiography in Yokohama University Hospital.
Basic objectives2
Others
Basic objectives -Others
epidemiologic research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Plasmma enzymatic activity of alpha-GAL A
2. Plasma globotriaosylsphingosine(Lyso-GB3)
Key secondary outcomes
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 5ml 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Petients participate in this trial on their own will.
Key exclusion criteria
Patients can't participate in this trial on their own will, with dementia, et al.
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Yatsu |
Organization
Yokohama City University Graduate School of Medicine
Division name
Medical Science and Cardiorenal Medicine
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2511
k-yatsu@be.wakwak.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minako Kagimoto |
Organization
Yokohama City University Graduate School of Medicine
Division name
Medical Science and Cardiorenal Medicine
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2511
Homepage URL
minako@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
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
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 | 11 | Month | 04 | 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 | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018118
| Research Plan | |
|---|---|
| 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 |
