Overview

This trial is active, not recruiting.

Condition coronary artery bypass grafting
Treatments conventional coronary artery bypass, off-pump coronary artery bypass, pump-assisted coronary artery bypass
Phase phase 3
Sponsor Martin-Luther-Universität Halle-Wittenberg
Collaborator Medtronic
Start date January 2003
End date September 2006
Trial size 616 participants
Trial identifier NCT00999089, 3CAB-STUDY

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Conventional Coronary Artery Bypass
conventional coronary artery bypass
Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
(Active Comparator)
Off-Pump Coronary Artery Bypass
off-pump coronary artery bypass
Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
(Active Comparator)
Pump-Assisted Coronary Artery Bypass
pump-assisted coronary artery bypass
Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients
Principal investigator Jochen Boergermann, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Martin-Luther-Universität Halle-Wittenberg.