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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024061
Receipt No. R000027706
Scientific Title Long-term prognosis and risk assessment in idiopathic ventricular fibrillation including Brugada syndrome
Date of disclosure of the study information 2016/09/18
Last modified on 2016/09/15

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Basic information
Public title Long-term prognosis and risk assessment in idiopathic ventricular fibrillation including Brugada syndrome
Acronym Japan Idiopathic Ventricular Fibrillation Study
Scientific Title Long-term prognosis and risk assessment in idiopathic ventricular fibrillation including Brugada syndrome
Scientific Title:Acronym Japan Idiopathic Ventricular Fibrillation Study
Region
Japan

Condition
Condition Idiopathic ventricular fibrillation including Brugada syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate long-term prognosis and risk stratification in idiopathic ventricular fibrillation including Brugada syndrome
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of sudden cardiac death and/or ventricular fibrillation (including ICD-documented ventricular fibrillation)
Key secondary outcomes Assessment of risk factors for cardiac events in clinical, electrocardiac, and electrophysiologic characteristics

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with idiopathic ventricular fibrillation including Brugada syndrome
Key exclusion criteria Patients with ventricular fibrillation due to reversible causes or underlying structural heart diseases.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aonuma
Organization Japan Idiopathic Ventricular Fibrillation Study
Division name Secretary general
Zip code
Address 1-1-1 Tenoudai Tsukuba City, Ibaraki
TEL 029-853-3142
Email j-ivfs@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Sekiguchi
Organization Japan Idiopathic Ventricular Fibrillation Study
Division name Secretary general
Zip code
Address 1-1-1 Tenoudai Tsukuba City, Ibaraki
TEL 029-853-3142
Homepage URL http://senmon-i.jp/j-ivfs/
Email j-ivfs@md.tsukuba.ac.jp

Sponsor
Institute Japan Idiopathic Ventricular Fibrillation Study
Institute
Department

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
Email

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 09 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2002 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2002 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information annual follow-up for incidence of sudden cardiac death and/or ventricular fibrillation

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027706

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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