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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007683
Receipt No. R000009051
Scientific Title Japan - Noninvasive Electrocardiographic Risk Stratification Study for Prediction of Sudden Cardiac Death
Date of disclosure of the study information 2012/04/16
Last modified on 2012/04/06

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Basic information
Public title Japan - Noninvasive Electrocardiographic Risk Stratification Study for Prediction of Sudden Cardiac Death
Acronym JANIES Study
Scientific Title Japan - Noninvasive Electrocardiographic Risk Stratification Study for Prediction of Sudden Cardiac Death
Scientific Title:Acronym JANIES Study
Region
Japan

Condition
Condition Patients who were measured electrocardiographic markers using 24-hour Holter monitoring
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate prospectively electrocardiographic markers such as TWA, LP, HRT, measured on 24-hour Holter monitoring by a multicenter study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality, cardiac mortality, arrhythmic mortality, sudden cardiac death
Key secondary outcomes Non-fetal arrhythmic events, operation of ICDs

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are able to undergo 24-hour Holter monitoring
Key exclusion criteria Patients who cannot visit outpatient clinic
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Ikeda
Organization Toho University Omori Medical Center
Division name Division of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Abe
Organization Toho University Omori Medical Center
Division name Division of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Homepage URL
Email janiesstudy@gmail.com

Sponsor
Institute JANIES Study Group
Institute
Department

Funding Source
Organization Scientific Research Grant from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 旭川医科大学付属病院(北海道)、自治医科大学付属病院(栃木県)、杏林大学医学部付属病院(東京都)、日本大学医学部付属板橋病院(東京都)、横浜南共済病院(神奈川県)、東海大学医学部付属病院(神奈川県)、岐阜大学医学部付属病院(岐阜県)、大阪市立大学医学部付属病院(大阪府)、広島大学医学部付属病院、大分大学医学部付属病院(大分県)、東邦大学医療センター大森病院(東京都)、山形大学医学部付属病院(山形県)、群馬県立心臓血管センター(群馬県)、富山大学医学部付属病院(富山県)、獨協医科大学越谷病院(埼玉県)、岡山大学医学部付属病院(岡山県)、福山市民病院(岡山県)、久留米大学医学部付属病院(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 16 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
2012 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 06 Month 01 Day
Date analysis concluded
2015 Year 08 Month 01 Day

Other
Other related information Confirmation of cardiac events at outpatient clinic in each institute

Management information
Registered date
2012 Year 04 Month 06 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009051

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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