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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00606372
First received: January 22, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: 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.

Resource links provided by NLM:

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 ]

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

No publications provided

Responsible Party: Prof. MUDr. Zbynek Straka, CSc., Kralovske Vinohrady University Hospital
ClinicalTrials.gov Identifier: NCT00606372     History of Changes
Other Study ID Numbers: 240376
Study First Received: January 22, 2008
Last Updated: January 22, 2008
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Postoperative Complications
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013