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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00719667
First received: July 20, 2008
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: German Off Pump Coronary Artery Bypass in Elderly Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Off Pump Coronary Artery Bypass in Elderly Study Group:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]
  • Any revascularisation [ Time Frame: 1 month and30 month ] [ Designated as safety issue: No ]
  • renal failure [ Time Frame: 1 month and 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ventilation time [ Time Frame: post op ] [ Designated as safety issue: No ]
  • blood transfusion [ Time Frame: post op ] [ Designated as safety issue: No ]
  • length of stay in intensive-care unit [ Time Frame: post op ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by German Off Pump Coronary Artery Bypass in Elderly Study Group

Additional 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
Study First Received: July 20, 2008
Last Updated: October 17, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Off Pump Coronary Artery Bypass in Elderly Study Group:
OPCAB
coronary
bypass
grafting
off pump

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013