On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+) (PRAGUE 6+)
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ClinicalTrials.gov Identifier: NCT00606372 |
Recruitment Status : Unknown
Verified January 2008 by Charles University, Czech Republic.
Recruitment status was: Enrolling by invitation
First Posted : February 4, 2008
Last Update Posted : February 4, 2008
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Condition or disease | Intervention/treatment |
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Ischemic Heart Disease Post-Operative Complications | Procedure: OPCAB - the off-pump coronary artery bypass |
Study Type : | Observational |
Estimated Enrollment : | 220 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass. |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | December 2009 |

Group/Cohort | Intervention/treatment |
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1
Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass
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2
Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass
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Procedure: OPCAB - the off-pump coronary artery bypass
surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart |
- death, heart stroke, brain stroke, renal failure, early reoperation [ Time Frame: 30 days ]
- heart stroke, brain stroke, death, renal failure, early reoperation [ Time Frame: 30 days and 365 days ]
- length of in-hospital stay, blood losses, number of blood-transfusion, new appeared atrial fibrillation, 1-year mortality, quality of life-angina classified by CCS in 1-year follow up, length of mechanical ventilation [ Time Frame: 30 days and 365 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- stable form of ischemic heart disease
- unstable angina pectoris
- acute myocardial infarction
- additive EuroSCORE 6 and more
- informed approval of the patient
Exclusion Criteria:
- significant heart valve disease, requesting surgery
- aortic aneurysm requesting surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606372
Czech Republic | |
Kralovske Vinohrady University Hospital | |
Prague, Czech Republic, 10034 | |
2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague | |
Prague, Czech Republic, 11000 |
Principal Investigator: | Zbynek Straka, 1 | Charles University, Prague |
Responsible Party: | Prof. MUDr. Zbynek Straka, CSc., Kralovske Vinohrady University Hospital |
ClinicalTrials.gov Identifier: | NCT00606372 |
Other Study ID Numbers: |
240376 |
First Posted: | February 4, 2008 Key Record Dates |
Last Update Posted: | February 4, 2008 |
Last Verified: | January 2008 |
Off-pump OPCAB EuroSCORE |
high-risk patients Quality of life Validity of EuroSCORE |
Heart Diseases Myocardial Ischemia Coronary Artery Disease Postoperative Complications Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |