On-Pump vs. Off-Pump CABG in High-Risk Patients (EuroSCORE 6+)
PRAGUE 6+
Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.
1 other identifier
observational
220
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 4, 2008
January 1, 2008
2.5 years
January 22, 2008
January 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
death, heart stroke, brain stroke, renal failure, early reoperation
30 days
heart stroke, brain stroke, death, renal failure, early reoperation
30 days and 365 days
Secondary Outcomes (1)
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
Study Arms (2)
1
Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated with use of the cardio-pulmonary bypass
2
Patients with ischemic heart disease, with EuroSCORE 6 additive points and more, operated without use of the cardio-pulmonary bypass
Interventions
surgical myocardial revascularisation without use of cardio-pulmonary bypass, using stabilising devices on beating heart
Eligibility Criteria
People indicated for surgical myocardial revascularisation with high surgical risk
You may qualify if:
- stable form of ischemic heart disease
- unstable angina pectoris
- acute myocardial infarction
- additive EuroSCORE 6 and more
- informed approval of the patient
You may not qualify if:
- significant heart valve disease, requesting surgery
- aortic aneurysm requesting surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kralovske Vinohrady University Hospital
Prague, 10034, Czechia
2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague
Prague, 11000, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zbynek Straka, 1
Charles University, Prague
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 4, 2008
Study Start
June 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
February 4, 2008
Record last verified: 2008-01