German Off Pump Coronary Artery Bypass in Elderly Study - Full Text View

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

This study is currently recruiting participants.

Verified by German Off Pump Coronary Artery Bypass in Elderly Study Group, July 2008

First Received: July 20, 2008 Last Updated: July 21, 2008 History of Changes

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
Information provided by:	German Off Pump Coronary Artery Bypass in Elderly Study Group
ClinicalTrials.gov Identifier:	NCT00719667

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 III

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	German Off Pump Coronary Artery Bypass in Elderly Study

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
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Anno Diegeler, Professor	00499771662416	a.diegeler@herzchirurgie.de
Contact: Michael Hilker, PD	00499419449804	michael.hilker@klinik.uni-regensburg.de

Locations

Germany, Bayern
Universität Regensburg	Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Michael Hilker, PD 004909419449804 michael.hilker@klinik.uni-regensburg.de
Principal Investigator: Michael Hilker, PD
Herzchirurgie Neustadt/Saale	Recruiting
Neustadt/Saale, Bayern, Germany, 97616
Contact: Anno Diegeler, Professor 00499771662416 a.diegeler@herzchirurgie.de
Contact: Anno Diegeler, Professor 000499771662416 a.diegeler@herzchirurgie.de
Principal Investigator: Anno Diegeler, Professor

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

Responsible Party:	GOPCABE Study Group ( Prof. Dr. med. Anno Diegeler and PD Dr. Michael Hilker )
Study ID Numbers:	op 001
Study First Received:	July 20, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00719667 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by German Off Pump Coronary Artery Bypass in Elderly Study Group:

OPCAB
coronary
bypass
grafting
off pump

Study placed in the following topic categories:

Heart Diseases

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009