UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023122 |
|---|---|
| Receipt number | R000026654 |
| Scientific Title | Multicenter survey of the idiopathic ventricular fibrillation |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2022/01/14 16:42:21 |
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Basic information
Public title
Multicenter survey of the idiopathic ventricular fibrillation
Acronym
Multicenter survey of the idiopathic ventricular fibrillation
Scientific Title
Multicenter survey of the idiopathic ventricular fibrillation
Scientific Title:Acronym
Multicenter survey of the idiopathic ventricular fibrillation
Region
| Japan |
Condition
Condition
Idiopathic ventricular fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to investigate the clinical characteristics and prognosis of patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarization syndrome, idiopathic ventricular fibrillation of unknown etioloty) in a prospective manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between clinical characteristics and prognosis in patients with 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarization syndrome, idiopathic ventricular fibrillation of unknown etiology)
Key exclusion criteria
none
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular medicine
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
kusanokengo@hotmail.com
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kusano |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular medicine
Zip code
564-8565
Address
6-1, Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
kusanokengo@hotmail.com
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
a grant from Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1, Kishibeshinmachi, Suita, Osaka
Tel
06-6170-1070
kusanokengo@hotmail.com
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 | 07 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective study.
We are going to evaluate the clinical characteristics and prognosis of patients with idiopathic ventricular fibrillation and an implantable cardioverter defibrillator.
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026654
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| Registered date | File name |
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| Registered date | File name |
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