UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027483 |
|---|---|
| Receipt number | R000031483 |
| Scientific Title | Long term results of off-pump coronary artery bypass grafting: analysis using Japanese Adult Cardiovascular Surgery Database. |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2022/05/29 13:03:42 |
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Basic information
Public title
Long term results of off-pump coronary artery bypass grafting: analysis using Japanese Adult Cardiovascular Surgery Database.
Acronym
Long term results of coronary surgery in Japan
Scientific Title
Long term results of off-pump coronary artery bypass grafting: analysis using Japanese Adult Cardiovascular Surgery Database.
Scientific Title:Acronym
Long term results of coronary surgery in Japan
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of long term results of on and off coronary artery bypass surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality, myocardial infarction, stroke, revascularization, patency of the graft
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
isolated coronary artery bypass
between 2008 and 2010
Key exclusion criteria
redo surgery
emergency surgery
Target sample size
5910
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Yaku |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
6028566
Address
465 Kajiicho Kamigyo Kyoto JAPAN
TEL
0752515752
yakuh@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Numata |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
6028566
Address
465 Kajiicho Kamigyo Kyoto JAPAN
TEL
0752515752
Homepage URL
snumat@yahoo.co.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Kyoto Prefectural University of Medicine.
Address
465 Kajiicho Kamigyo Kyoto JAPAN
Tel
0752515337
kpu@bvits.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
| 2017 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7724
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the long term surgical results of coronary artery bypass grafting with or without cardiopulmonary bypass using japanese adult cardiovascular surgery database.
Management information
Registered date
| 2017 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031483
