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

January 22, 2008 updated by: Charles University, Czech Republic

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 10034
        • Kralovske Vinohrady University Hospital
      • Prague, Czech Republic, 11000
        • 2nd Surgical Dpt. of 1st Faculty of Medicine of Charles University, Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People indicated for surgical myocardial revascularisation with high surgical risk

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death, heart stroke, brain stroke, renal failure, early reoperation
Time Frame: 30 days
30 days
heart stroke, brain stroke, death, renal failure, early reoperation
Time Frame: 30 days and 365 days
30 days and 365 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 days and 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Zbynek Straka, 1, Charles University, Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2008

Last Update Submitted That Met QC Criteria

January 22, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240376

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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