UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000124
Receipt number 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 15:19:40

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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 or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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