search
Back to results

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

Primary Purpose

Heart Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
coronary artery bypass grafting
Sponsored by
German Off Pump Coronary Artery Bypass in Elderly Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring OPCAB, coronary, bypass, grafting, off pump

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzchirurgie Neustadt/Saale
  • Universität Regensburg

Outcomes

Primary Outcome Measures

All cause mortality
Myocardial infarction
Stroke
Any revascularisation
renal failure

Secondary Outcome Measures

ventilation time
blood transfusion
length of stay in intensive-care unit

Full Information

First Posted
July 20, 2008
Last Updated
October 17, 2011
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
search

1. Study Identification

Unique Protocol Identification Number
NCT00719667
Brief Title
German Off Pump Coronary Artery Bypass in Elderly Study
Acronym
GOPCABE
Official Title
German Off Pump Coronary Artery Bypass in Elderly Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
OPCAB, coronary, bypass, grafting, off pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
coronary artery bypass grafting
Intervention Description
on pump off pump
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
1 month and 12 month
Title
Myocardial infarction
Time Frame
1 month and 12 month
Title
Stroke
Time Frame
1 month and 12 month
Title
Any revascularisation
Time Frame
1 month and30 month
Title
renal failure
Time Frame
1 month and 12 month
Secondary Outcome Measure Information:
Title
ventilation time
Time Frame
post op
Title
blood transfusion
Time Frame
post op
Title
length of stay in intensive-care unit
Time Frame
post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anno Diegeler, Professor
Organizational Affiliation
Herzchirurgie Bad Neustadt/Saale
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Hilker, PD
Organizational Affiliation
Universität Regensburg
Official's Role
Study Chair
Facility Information:
Facility Name
Herzchirurgie Neustadt/Saale
City
Neustadt/Saale
State/Province
Bayern
ZIP/Postal Code
97616
Country
Germany
Facility Name
Universität Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30732456
Citation
Diegeler A, Borgermann J, Kappert U, Hilker M, Doenst T, Boning A, Albert M, Farber G, Holzhey D, Conradi L, Riess FC, Veeckmann P, Minorics C, Zacher M, Reents W. Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients. Circulation. 2019 Apr 16;139(16):1865-1871. doi: 10.1161/CIRCULATIONAHA.118.035857.
Results Reference
derived
PubMed Identifier
28854266
Citation
Faerber G, Zacher M, Reents W, Boergermann J, Kappert U, Boening A, Diegeler A, Doenst T; GOPCABE investigators. Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial. PLoS One. 2017 Aug 30;12(8):e0184038. doi: 10.1371/journal.pone.0184038. eCollection 2017.
Results Reference
derived
PubMed Identifier
23477657
Citation
Diegeler A, Borgermann J, Kappert U, Breuer M, Boning A, Ursulescu A, Rastan A, Holzhey D, Treede H, Riess FC, Veeckmann P, Asfoor A, Reents W, Zacher M, Hilker M; GOPCABE Study Group. Off-pump versus on-pump coronary-artery bypass grafting in elderly patients. N Engl J Med. 2013 Mar 28;368(13):1189-98. doi: 10.1056/NEJMoa1211666. Epub 2013 Mar 11.
Results Reference
derived

Learn more about this trial

German Off Pump Coronary Artery Bypass in Elderly Study

We'll reach out to this number within 24 hrs