Arrested Versus Beating Heart Techniques in Coronary Revascularisation

NCT ID: NCT00999089

Last Updated: 2009-10-21

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

616 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CCAB

Conventional Coronary Artery Bypass

Group Type ACTIVE_COMPARATOR

Conventional Coronary Artery Bypass

Intervention Type PROCEDURE

Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest

OPCAB

Off-Pump Coronary Artery Bypass

Group Type ACTIVE_COMPARATOR

Off-Pump Coronary Artery Bypass

Intervention Type PROCEDURE

Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia

PACAB

Pump-Assisted Coronary Artery Bypass

Group Type ACTIVE_COMPARATOR

Pump-Assisted Coronary Artery Bypass

Intervention Type PROCEDURE

Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

Interventions

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Conventional Coronary Artery Bypass

Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest

Intervention Type PROCEDURE

Off-Pump Coronary Artery Bypass

Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia

Intervention Type PROCEDURE

Pump-Assisted Coronary Artery Bypass

Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Jochen Boergermann, MD

Role: PRINCIPAL_INVESTIGATOR

Martin-Luther-University Halle-Wittenberg

Rolf E Silber, MD

Role: STUDY_CHAIR

Martin-Luther-University Halle-Wittenberg

Locations

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Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery

Coswig, , Germany

Site Status

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

Halle, , Germany

Site Status

Countries

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Germany

Other Identifiers

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3CAB-STUDY

Identifier Type: -

Identifier Source: org_study_id

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