On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)

• Conditions: Ischemic Heart Disease; Post-Operative Complications
• Interventions: Procedure: OPCAB - the off-pump coronary artery bypass

• Registration Number: NCT00606372
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

Previous studies comparing on-pump and off-pump operating strategy did only partially demonstrate benefits of the off-pump myocardial revascularisation.In primary end-points (MI, death, renal failure, and so on) there was no significant difference, but in secondary end-points we observed benefits resulting for patients. We would like to show the benefit of the method without extracorporeal circulation in patients with higher and hight operation risk, coming from EuroSCORE classification system (6 points and more).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Status Verified: 2008-01
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Last Update Submitted: 2008-01-22
• Study First Posted: 2008-02-04
• Last Update Posted: 2008-02-04
• Primary Completion: 2008-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	OPCAB - the off-pump coronary artery bypass	Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass

Primary Outcome Measures

Name	Time	Method
heart stroke, brain stroke, death, renal failure, early reoperation	30 days and 365 days
death, heart stroke, brain stroke, renal failure, early reoperation	30 days

Secondary Outcome Measures

Name	Time	Method
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	30 days and 365 days

Trial Locations

Locations (2)

Kralovske Vinohrady University Hospital; 🇨🇿 Prague, Czech Republic

2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague; 🇨🇿 Prague, Czech Republic