Unique ID issued by UMIN | C000000124 |
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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 |
Japanese Off-Pump Coronary Artery Revascularization Investigation
JOCRI
Japanese Off-Pump Coronary Artery Revascularization Investigation
JOCRI
Japan |
Patients with two or three vessel coronary artery disease who need coronary artery bypass grafting
Cardiovascular surgery |
Others
NO
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.
Bio-equivalence
Confirmatory
Explanatory
Not applicable
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.
The secondary endpoints were completeness of revascularization, early clinical outcomes, and neurocognitive function.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Maneuver |
Coronary artery bypass grafting with cardiopulmonary bypass
Coronary artery bypass grafting without cardiopulmonary bypass
15 | years-old | <= |
70 | years-old | > |
Male and Female
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.
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.
280
1st name | |
Middle name | |
Last name | Junjiro Kobayashi |
National Cardiovascular Center
Department of Cardiovascular Surgery
5-7-1 Fujishiro-dai, Suita, Osaka, Japan
06-6833-5012
1st name | |
Middle name | |
Last name | Junjiro Kobayashi |
National Cardiovascular Center
Department of Cardiovascular Surgery
5-7-1 Fujishiro-dai, Suita, Osaka, Japan
06-6833-5012
jkobayas@hsp.ncvc.go.jp
National Cardiovascular Center
Japanese Ministry of Health, Labor, and Welfare
Japan
NO
2005 | Year | 11 | Month | 01 | Day |
Unpublished
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.
No longer recruiting
2002 | Year | 06 | Month | 30 | Day |
2002 | Year | 07 | Month | 01 | Day |
2008 | Year | 06 | Month | 01 | Day |
2005 | Year | 09 | Month | 07 | Day |
2005 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000184
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