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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Bypass Grafting
Procedure: Conventional Coronary Artery Bypass
Procedure: Off-Pump Coronary Artery Bypass
Procedure: Pump-Assisted Coronary Artery Bypass
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 616
Study Start Date: January 2003
Estimated Study Completion Date: September 2010
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CCAB
Conventional Coronary Artery Bypass
Procedure: Conventional Coronary Artery Bypass
Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
Active Comparator: OPCAB
Off-Pump Coronary Artery Bypass
Procedure: Off-Pump Coronary Artery Bypass
Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
Active Comparator: PACAB
Pump-Assisted Coronary Artery Bypass
Procedure: Pump-Assisted Coronary Artery Bypass
Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999089

Locations
Germany
Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery
Coswig, Germany, 06869
Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery
Halle/Saale, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Medtronic
Investigators
Principal Investigator: Jochen Boergermann, MD Martin-Luther-University Halle-Wittenberg
Study Chair: Rolf E Silber, MD Martin-Luther-University Halle-Wittenberg
  More Information

No publications provided

Responsible Party: Jochen Boergermann, Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery
ClinicalTrials.gov Identifier: NCT00999089     History of Changes
Other Study ID Numbers: 3CAB-STUDY
Study First Received: October 19, 2009
Last Updated: October 20, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Coronary disease
Coronary artery bypass grafting
Cardiopulmonary bypass
Extracorporeal circulation
Cardioplegia
Off pump

ClinicalTrials.gov processed this record on August 26, 2014