German Off Pump Coronary Artery Bypass in Elderly Study (GOPCABE)

October 17, 2011 updated by: PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group

Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.

Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

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

  • Germany
    • Bayern
      • Neustadt/Saale, Bayern, Germany, 97616
        • Herzchirurgie Neustadt/Saale
      • Regensburg, Bayern, Germany, 93053
        • Universitat Regensburg

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

Description

Inclusion Criteria:

  • older or 75 years
  • indication for elective bypass operation
  • patient has signed written consent before randomization

Exclusion Criteria:

  • previous heart surgery
  • patient unable to give informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 1 month and 12 month
1 month and 12 month
Myocardial infarction
Time Frame: 1 month and 12 month
1 month and 12 month
Stroke
Time Frame: 1 month and 12 month
1 month and 12 month
Any revascularisation
Time Frame: 1 month and30 month
1 month and30 month
renal failure
Time Frame: 1 month and 12 month
1 month and 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
ventilation time
Time Frame: post op
post op
blood transfusion
Time Frame: post op
post op
length of stay in intensive-care unit
Time Frame: post op
post op

Collaborators and Investigators

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

Sponsor

German Off Pump Coronary Artery Bypass in Elderly Study Group

Collaborators

Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie

Investigators

  • Principal Investigator: Anno Diegeler, Professor, Herzchirurgie Bad Neustadt/Saale
  • Study Chair: Michael Hilker, PD, Universitat Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 20, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 18, 2011

Last Update Submitted That Met QC Criteria

October 17, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • op 001

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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