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German Off Pump Coronary Artery Bypass in Elderly Study

NCT ID: NCT00719667

Last Updated: 2011-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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coronary artery bypass grafting

on pump off pump

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Klinisch-Kardiovaskuläre Forschung GmbH

NETWORK

Sponsor Role collaborator

Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie

UNKNOWN

Sponsor Role collaborator

German Off Pump Coronary Artery Bypass in Elderly Study Group

NETWORK

Sponsor Role lead

Responsible Party

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PD Dr. Michael Hilker

Professor Hilker

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anno Diegeler, Professor

Role: PRINCIPAL_INVESTIGATOR

Herzchirurgie Bad Neustadt/Saale

Michael Hilker, PD

Role: STUDY_CHAIR

Universität Regensburg

Locations

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Herzchirurgie Neustadt/Saale

Neustadt/Saale, Bavaria, Germany

Site Status

Universität Regensburg

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30732456 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28854266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23477657 (View on PubMed)

Other Identifiers

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op 001

Identifier Type: -

Identifier Source: org_study_id