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

Ischemic Heart Disease Clinical Trial

— PRAGUE 6+  

Official title:

Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00606372
• Other study ID #: 240376
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 22, 2008
• Last updated: January 22, 2008
• Start date: June 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2008
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia
• Post-Operative Complications
• Postoperative Complications

Intervention

Procedure:
• OPCAB - the off-pump coronary artery bypass
surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart

Locations

Country	Name	City	State
Czech Republic	2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague	Prague
Czech Republic	Kralovske Vinohrady University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death, heart stroke, brain stroke, renal failure, early reoperation		30 days	Yes
Primary	heart stroke, brain stroke, death, renal failure, early reoperation		30 days and 365 days	Yes
Secondary	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	Yes