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Arrested Versus Beating Heart Techniques in Coronary Revascularisation

NCT00999089 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2009-10-21

No results posted yet for this study

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.

Conditions

  • Coronary Artery Bypass Grafting

Interventions

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Principal Investigators

  • Jochen Boergermann, MD · Martin-Luther-University Halle-Wittenberg

  • Rolf E Silber, MD · Martin-Luther-University Halle-Wittenberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2006-09-30
Completion
2010-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999089 on ClinicalTrials.gov