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

Charles University, Czech Republic

Status: Unknown

Conditions: Ischemic Heart Disease; Post-Operative Complications

Treatments: Procedure: OPCAB - the off-pump coronary artery bypass

Study type: Observational

Funder types: Other

Identifiers

NCT00606372

240376

Details and patient eligibility

About

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).

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 2 patient groups

1

Description:

Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass

2

Description:

Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass

Treatment:

Procedure: OPCAB - the off-pump coronary artery bypass