Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Phase 3

• Conditions: Coronary Artery Bypass Grafting
• Interventions: Procedure: Pump-Assisted Coronary Artery Bypass; Procedure: Conventional Coronary Artery Bypass; Procedure: Off-Pump Coronary Artery Bypass

• Registration Number: NCT00999089
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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 available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-20
• Last Update Submitted: 2009-10-20
• Study First Posted: 2009-10-21
• Last Update Posted: 2009-10-21
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 616

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

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Exclusion Criteria

• previous cardiac surgery
• emergency indications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACAB	Pump-Assisted Coronary Artery Bypass	Pump-Assisted Coronary Artery Bypass
CCAB	Conventional Coronary Artery Bypass	Conventional Coronary Artery Bypass
OPCAB	Off-Pump Coronary Artery Bypass	Off-Pump Coronary Artery Bypass

Primary Outcome Measures

Name	Time	Method
Stroke	1, 6, 12, 24, 48 month
Low-output syndrome	in hospital
Myocardial infarction	1, 6, 12, 24, 48 month
New requirement of hemodialysis	in hospital
duration of ventilation >= 24h	in hospital
All cause mortality	1, 6, 12, 24, 48 month

Secondary Outcome Measures

Name	Time	Method
Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)	in hospital
Completeness of revascularization	in hospital
Re-revascularization of the target vessel (PCI and/or CABG)	1, 6, 12, 24, 48 month

Trial Locations

Locations (2)

Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery; 🇩🇪 Coswig, Germany

Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery; 🇩🇪 Halle/Saale, Germany