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

Sponsored by:	Charles University, Czech Republic
Information provided by:	Charles University, Czech Republic
ClinicalTrials.gov Identifier:	NCT00606372

Purpose

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).

Condition	Intervention
Ischemic Heart Disease Post-Operative Complications	Procedure: OPCAB - the off-pump coronary artery bypass

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Diseases Kidney Failure

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:

death, heart stroke, brain stroke, renal failure, early reoperation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
heart stroke, brain stroke, death, renal failure, early reoperation [ Time Frame: 30 days and 365 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	220
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

People indicated for surgical myocardial revascularisation with high surgical risk

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606372

Locations

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

Sponsors and Collaborators

Charles University, Czech Republic

Investigators

Principal Investigator:

Zbynek Straka, 1

Charles University, Prague

More Information

Additional Information:

Off-pump versus on-pump coronary surgery: final results from a prospective randomized study Prague-4 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kralovske Vinohrady University Hospital ( Prof. MUDr. Zbynek Straka, CSc. )
Study ID Numbers:	240376
Study First Received:	January 22, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00606372 History of Changes
Health Authority:	Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:

Off-pump
OPCAB
EuroSCORE

high-risk patients
Quality of life
Validity of EuroSCORE

Study placed in the following topic categories:

Heart Diseases
Postoperative Complications
Myocardial Ischemia

Vascular Diseases
Quality of Life
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Postoperative Complications

Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 03, 2009