NCT00719667

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

3.3 years

First QC Date

July 20, 2008

Last Update Submit

October 17, 2011

Conditions

Heart Disease

Keywords

OPCABcoronarybypassgraftingoff pump

Outcome Measures

Primary Outcomes (5)

  • All cause mortality

    1 month and 12 month

  • Myocardial infarction

    1 month and 12 month

  • Stroke

    1 month and 12 month

  • Any revascularisation

    1 month and30 month

  • renal failure

    1 month and 12 month

Secondary Outcomes (3)

  • ventilation time

    post op

  • blood transfusion

    post op

  • length of stay in intensive-care unit

    post op

Interventions

coronary artery bypass graftingOTHER

on pump off pump

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous heart surgery
  • patient unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herzchirurgie Neustadt/Saale

Neustadt/Saale, Bavaria, 97616, Germany

Location

Universität Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (3)

  • 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.

    PMID: 30732456DERIVED

  • 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.

    PMID: 28854266DERIVED

  • 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.

    PMID: 23477657DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Anno Diegeler, Professor

    Herzchirurgie Bad Neustadt/Saale

    PRINCIPAL INVESTIGATOR

  • Michael Hilker, PD

    Universität Regensburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Hilker

Study Record Dates

First Submitted

July 20, 2008

First Posted

July 22, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

DE(2)