UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020611 |
|---|---|
| Receipt number | R000023792 |
| Scientific Title | Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2019/01/20 14:38:29 |
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Basic information
Public title
Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Acronym
Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Scientific Title
Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Scientific Title:Acronym
Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Region
| Japan |
Condition
Condition
idiopathic ventricular fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relation between sex hormone and clinical characteristics in patients with idiopathic ventricular fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between sex hormone (testosterone) and clinical characteristics in idiopathic ventricular fibrillation
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarizaton syndrome, idiopathic ventricular fibrillation of unknown cause) in the National Cerebral and Cardiovascular Center)
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kusano Kengo |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
kusanokengo@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kusano Kengo |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
kusanokengo@hotmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Intramural research funds (22-1-2) for cardiovascular disease from National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 01 | Month | 18 | 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
We could not find no relationship between the serum level of testosterone and occurence of ventricular fibrillation during 2 years follow-up period.
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
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is a single center, prospective and retrospective study.
We are going to take blood samples and evaluate sex hormone (testosterone, etc) in patients with idiopathic ventricular fibrillation, who have been admitted to the National Cerebral and Cardiovascular Center since January, 2016.
Management information
Registered date
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2019 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023792
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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