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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 22, 2013