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

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ClinicalTrials.gov Identifier: NCT00719667
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : October 18, 2011
Sponsor:
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

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Heart Disease Other: coronary artery bypass grafting Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: German Off Pump Coronary Artery Bypass in Elderly Study
Study Start Date : July 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Other: coronary artery bypass grafting
    on pump off pump

Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 1 month and 12 month ]
  2. Myocardial infarction [ Time Frame: 1 month and 12 month ]
  3. Stroke [ Time Frame: 1 month and 12 month ]
  4. Any revascularisation [ Time Frame: 1 month and30 month ]
  5. renal failure [ Time Frame: 1 month and 12 month ]

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

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
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
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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
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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
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Principal Investigator: Anno Diegeler, Professor Herzchirurgie Bad Neustadt/Saale
Study Chair: Michael Hilker, PD Universität Regensburg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PD Dr. Michael Hilker, Professor Hilker, German Off Pump Coronary Artery Bypass in Elderly Study Group
ClinicalTrials.gov Identifier: NCT00719667    
Other Study ID Numbers: op 001
First Posted: July 22, 2008    Key Record Dates
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:
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Heart Diseases
Cardiovascular Diseases