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

October 19, 2009
October 20, 2009
January 2003
September 2006   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00999089 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Arrested Versus Beating Heart Techniques in Coronary Revascularisation
Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Bypass Grafting
  • Procedure: Conventional Coronary Artery Bypass
    Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
  • Procedure: Off-Pump Coronary Artery Bypass
    Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
  • Procedure: Pump-Assisted Coronary Artery Bypass
    Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation
  • Active Comparator: CCAB
    Conventional Coronary Artery Bypass
    Intervention: Procedure: Conventional Coronary Artery Bypass
  • Active Comparator: OPCAB
    Off-Pump Coronary Artery Bypass
    Intervention: Procedure: Off-Pump Coronary Artery Bypass
  • Active Comparator: PACAB
    Pump-Assisted Coronary Artery Bypass
    Intervention: Procedure: Pump-Assisted Coronary Artery Bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
616
September 2010
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00999089
3CAB-STUDY
No
Jochen Boergermann, Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery
Martin-Luther-Universität Halle-Wittenberg
Medtronic
Principal Investigator: Jochen Boergermann, MD Martin-Luther-University Halle-Wittenberg
Study Chair: Rolf E Silber, MD Martin-Luther-University Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP