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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000124
Receipt No. R000000184
Scientific Title Japanese Off-Pump Coronary Artery Revascularization Investigation
Date of disclosure of the study information 2005/11/01
Last modified on 2005/09/07

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Basic information
Public title Japanese Off-Pump Coronary Artery Revascularization Investigation
Acronym JOCRI
Scientific Title Japanese Off-Pump Coronary Artery Revascularization Investigation
Scientific Title:Acronym JOCRI
Region
Japan

Condition
Condition Patients with two or three vessel coronary artery disease who need coronary artery bypass grafting
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 JOCRI-study is designed to compare the outcome of off-pump and on-pump coronary revascularization in patients with a low risk for cardiopulmonary bypass.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoints were 3-year cardiac events after CABG including acute myocardial infarction, admission by angina pectoris or congestive heart failure, cardiac death, and re-intervention.
Key secondary outcomes The secondary endpoints were completeness of revascularization, early clinical outcomes, and neurocognitive function.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Coronary artery bypass grafting with cardiopulmonary bypass
Interventions/Control_2 Coronary artery bypass grafting without cardiopulmonary bypass
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients for isolated, first-time CABG due to at least two vessel diseases younger than 70 years of age were eligible for enrollment in the study.
Key exclusion criteria The exclusion criteria were as follows: acute MI; an age of more than 70 years; an indication for additional surgical procedures; documented history of stroke; severe ascending aortic calcification by CT scanning; carotid arterial stenosis of more than 75% by Duplex scanning; acute Q-wave myocardial infarction which necessitates emergency operation; left ventricular ejection fraction of less than 30%; serum creatinine level of higher than 2.0 mg/dL; liver cirrhosis; chronic obstructive pulmonary disease that needs a bronchodilator or steroid; pulmonary hypertension with a mean pulmonary artery pressure >25mmHg; other comorbidity which is not appropriate for CPB such as anomalous coagulation, cancer, and an inability to provide written informed consent.
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junjiro Kobayashi
Organization National Cardiovascular Center
Division name Department of Cardiovascular Surgery
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junjiro Kobayashi
Organization National Cardiovascular Center
Division name Department of Cardiovascular Surgery
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email jkobayas@hsp.ncvc.go.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfare
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

Other administrative information
Date of disclosure of the study information
2005 Year 11 Month 01 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
Off-pump CABG with multiple arterial grafts was as safe as the conventional on-pump CABG with similar completeness of revascularization and early graft patency.
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 No longer recruiting
Date of protocol fixation
2002 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2002 Year 07 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 07 Day
Last modified on
2005 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000184

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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