Arrested Versus Beating Heart Techniques in Coronary Revascularisation

October 20, 2009 updated by: Martin-Luther-Universität Halle-Wittenberg

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

616

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Coswig, Germany, 06869
        • Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery
      • Halle/Saale, Germany, 06120
        • Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Completeness of revascularization
Time Frame: in hospital
in hospital
Re-revascularization of the target vessel (PCI and/or CABG)
Time Frame: 1, 6, 12, 24, 48 month
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
in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

Medtronic

Investigators

  • Principal Investigator: Jochen Boergermann, MD, Martin-Luther-University Halle-Wittenberg
  • Study Chair: Rolf E Silber, MD, Martin-Luther-University Halle-Wittenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (ESTIMATE)

October 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2009

Last Update Submitted That Met QC Criteria

October 20, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3CAB-STUDY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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