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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719667
First Posted: July 22, 2008
Last Update Posted: October 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie
Information provided by (Responsible Party):
PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group
  Purpose

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).


Condition Intervention Phase
Heart Disease Other: coronary artery bypass grafting Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: German Off Pump Coronary Artery Bypass in Elderly Study

Resource links provided by NLM:


Further study details as provided by PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 1 month and 12 month ]
  • Myocardial infarction [ Time Frame: 1 month and 12 month ]
  • Stroke [ Time Frame: 1 month and 12 month ]
  • Any revascularisation [ Time Frame: 1 month and30 month ]
  • renal failure [ Time Frame: 1 month and 12 month ]

Secondary Outcome Measures:
  • ventilation time [ Time Frame: post op ]
  • blood transfusion [ Time Frame: post op ]
  • length of stay in intensive-care unit [ Time Frame: post op ]

Estimated Enrollment: 2000
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: coronary artery bypass grafting
    on pump off pump
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00719667


Locations
Germany
Herzchirurgie Neustadt/Saale
Neustadt/Saale, Bayern, Germany, 97616
Universität Regensburg
Regensburg, Bayern, Germany, 93053
Sponsors and Collaborators
German Off Pump Coronary Artery Bypass in Elderly Study Group
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 Universität Regensburg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Michael Hilker, Professor Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group
ClinicalTrials.gov Identifier: NCT00719667     History of Changes
Other Study ID Numbers: op 001
First Submitted: July 20, 2008
First Posted: July 22, 2008
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by PD Dr. Michael Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group:
OPCAB
coronary
bypass
grafting
off pump

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases