Arrested Versus Beating Heart Techniques in Coronary Revascularisation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Medtronic

Information provided by:

Martin-Luther-Universität Halle-Wittenberg

ClinicalTrials.gov Identifier:

NCT00999089

First received: October 19, 2009

Last updated: October 20, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 19, 2009

Last Updated Date

October 20, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

All cause mortality [ Time Frame: 1, 6, 12, 24, 48 month ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: 1, 6, 12, 24, 48 month ] [ Designated as safety issue: Yes ]
Stroke [ Time Frame: 1, 6, 12, 24, 48 month ] [ Designated as safety issue: Yes ]
Low-output syndrome [ Time Frame: in hospital ] [ Designated as safety issue: No ]
duration of ventilation >= 24h [ Time Frame: in hospital ] [ Designated as safety issue: No ]
New requirement of hemodialysis [ Time Frame: in hospital ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00999089 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Completeness of revascularization [ Time Frame: in hospital ] [ Designated as safety issue: No ]
Re-revascularization of the target vessel (PCI and/or CABG) [ Time Frame: 1, 6, 12, 24, 48 month ] [ Designated as safety issue: No ]
Resource use (operative time, duration of stay in the intensive care unit, total hospital stay) [ Time Frame: in hospital ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Official Title ^ICMJE

Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients

Brief Summary

The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Bypass Grafting

Intervention ^ICMJE

Procedure: Conventional Coronary Artery Bypass
Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
Procedure: Off-Pump Coronary Artery Bypass
Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
Procedure: Pump-Assisted Coronary Artery Bypass
Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

Study Arm (s)

Active Comparator: CCAB
Conventional Coronary Artery Bypass

Intervention: Procedure: Conventional Coronary Artery Bypass
Active Comparator: OPCAB
Off-Pump Coronary Artery Bypass

Intervention: Procedure: Off-Pump Coronary Artery Bypass
Active Comparator: PACAB
Pump-Assisted Coronary Artery Bypass

Intervention: Procedure: Pump-Assisted Coronary Artery Bypass

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

616

Estimated Completion Date

September 2010

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with double- or triple-vessel coronary artery disease
patients with left ventricular ejection fraction =< 40% or >= 60%
elective or urgent isolated coronary artery bypass grafting

Exclusion Criteria:

previous cardiac surgery
emergency indications

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00999089

Other Study ID Numbers ^ICMJE

3CAB-STUDY

Has Data Monitoring Committee

Responsible Party

Jochen Boergermann, Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery

Study Sponsor ^ICMJE

Martin-Luther-Universität Halle-Wittenberg

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:	Jochen Boergermann, MD	Martin-Luther-University Halle-Wittenberg
Study Chair:	Rolf E Silber, MD	Martin-Luther-University Halle-Wittenberg

Information Provided By

Martin-Luther-Universität Halle-Wittenberg

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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