UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007683 |
|---|---|
| Receipt number | 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 21:58:35 |
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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
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
janiesstudy@gmail.com
Sponsor or person
Institute
JANIES Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009051
| 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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| Registered date | File name |
