UMIN-CTR Clinical Trial

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
Email	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
Email	snumat@yahoo.co.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031483