Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Coronary Artery Bypass Grafting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00999089
• Other study ID #: 3CAB-STUDY
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 19, 2009
• Last updated: October 20, 2009
• Start date: January 2003
• Est. completion date: September 2010

Study information

• Verified date: October 2009
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 616
• Est. completion date: September 2010
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

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

Locations

Country	Name	City	State
Germany	Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery	Coswig
Germany	Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery	Halle/Saale

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		1, 6, 12, 24, 48 month	Yes
Primary	Myocardial infarction		1, 6, 12, 24, 48 month	Yes
Primary	Stroke		1, 6, 12, 24, 48 month	Yes
Primary	Low-output syndrome		in hospital	No
Primary	duration of ventilation >= 24h		in hospital	No
Primary	New requirement of hemodialysis		in hospital	No
Secondary	Completeness of revascularization		in hospital	No
Secondary	Re-revascularization of the target vessel (PCI and/or CABG)		1, 6, 12, 24, 48 month	No
Secondary	Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)		in hospital	No