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Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Primary Purpose

Coronary Artery Bypass Grafting

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Conventional Coronary Artery Bypass
Off-Pump Coronary Artery Bypass
Pump-Assisted Coronary Artery Bypass
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Bypass Grafting focused on measuring Coronary disease, Coronary artery bypass grafting, Cardiopulmonary bypass, Extracorporeal circulation, Cardioplegia, Off pump

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery
  • Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CCAB

OPCAB

PACAB

Arm Description

Conventional Coronary Artery Bypass

Off-Pump Coronary Artery Bypass

Pump-Assisted Coronary Artery Bypass

Outcomes

Primary Outcome Measures

All cause mortality
Myocardial infarction
Stroke
Low-output syndrome
duration of ventilation >= 24h
New requirement of hemodialysis

Secondary Outcome Measures

Completeness of revascularization
Re-revascularization of the target vessel (PCI and/or CABG)
Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)

Full Information

First Posted
October 19, 2009
Last Updated
October 20, 2009
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00999089
Brief Title
Arrested Versus Beating Heart Techniques in Coronary Revascularisation
Official Title
Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting
Keywords
Coronary disease, Coronary artery bypass grafting, Cardiopulmonary bypass, Extracorporeal circulation, Cardioplegia, Off pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
616 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCAB
Arm Type
Active Comparator
Arm Description
Conventional Coronary Artery Bypass
Arm Title
OPCAB
Arm Type
Active Comparator
Arm Description
Off-Pump Coronary Artery Bypass
Arm Title
PACAB
Arm Type
Active Comparator
Arm Description
Pump-Assisted Coronary Artery Bypass
Intervention Type
Procedure
Intervention Name(s)
Conventional Coronary Artery Bypass
Intervention Description
Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
Intervention Type
Procedure
Intervention Name(s)
Off-Pump Coronary Artery Bypass
Intervention Description
Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
Intervention Type
Procedure
Intervention Name(s)
Pump-Assisted Coronary Artery Bypass
Intervention Description
Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
1, 6, 12, 24, 48 month
Title
Myocardial infarction
Time Frame
1, 6, 12, 24, 48 month
Title
Stroke
Time Frame
1, 6, 12, 24, 48 month
Title
Low-output syndrome
Time Frame
in hospital
Title
duration of ventilation >= 24h
Time Frame
in hospital
Title
New requirement of hemodialysis
Time Frame
in hospital
Secondary Outcome Measure Information:
Title
Completeness of revascularization
Time Frame
in hospital
Title
Re-revascularization of the target vessel (PCI and/or CABG)
Time Frame
1, 6, 12, 24, 48 month
Title
Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)
Time Frame
in hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Boergermann, MD
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rolf E Silber, MD
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery
City
Coswig
ZIP/Postal Code
06869
Country
Germany
Facility Name
Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany

12. IPD Sharing Statement

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Arrested Versus Beating Heart Techniques in Coronary Revascularisation

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