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

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ClinicalTrials.gov Identifier: NCT00606372
Recruitment Status : Unknown
Verified January 2008 by Charles University, Czech Republic.
Recruitment status was:  Enrolling by invitation
First Posted : February 4, 2008
Last Update Posted : February 4, 2008
Sponsor:
Information provided by:
Charles University, Czech Republic

Study Description
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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).

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

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aortocoronary Bypasses in High-Risk Patients (EuroSCORE 6+) With or Without Use of the Cardio-Pulmonary Bypass.
Study Start Date : June 2006
Actual Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. death, heart stroke, brain stroke, renal failure, early reoperation [ Time Frame: 30 days ]
  2. heart stroke, brain stroke, death, renal failure, early reoperation [ Time Frame: 30 days and 365 days ]

Secondary Outcome Measures :
  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 [ Time Frame: 30 days and 365 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606372


Locations
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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
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Principal Investigator: Zbynek Straka, 1 Charles University, Prague
More Information
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Responsible Party: Prof. MUDr. Zbynek Straka, CSc., Kralovske Vinohrady University Hospital
ClinicalTrials.gov Identifier: NCT00606372    
Other Study ID Numbers: 240376
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: February 4, 2008
Last Verified: January 2008
Keywords provided by Charles University, Czech Republic:
Off-pump
OPCAB
EuroSCORE
 high-risk patients
Quality of life
Validity of EuroSCORE
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Postoperative Complications
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes