NCT00999089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
616

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

Enrollment Period

3.7 years

First QC Date

October 19, 2009

Last Update Submit

October 20, 2009

Conditions

Coronary Artery Bypass Grafting

Keywords

Coronary diseaseCoronary artery bypass graftingCardiopulmonary bypassExtracorporeal circulationCardioplegiaOff pump

Outcome Measures

Primary Outcomes (6)

  • All cause mortality

    1, 6, 12, 24, 48 month

  • Myocardial infarction

    1, 6, 12, 24, 48 month

  • Stroke

    1, 6, 12, 24, 48 month

  • Low-output syndrome

    in hospital

  • duration of ventilation >= 24h

    in hospital

  • New requirement of hemodialysis

    in hospital

Secondary Outcomes (3)

  • Completeness of revascularization

    in hospital

  • Re-revascularization of the target vessel (PCI and/or CABG)

    1, 6, 12, 24, 48 month

  • Resource use (operative time, duration of stay in the intensive care unit, total hospital stay)

    in hospital

Study Arms (3)

CCAB

ACTIVE COMPARATOR

Conventional Coronary Artery Bypass

Procedure: Conventional Coronary Artery Bypass

OPCAB

ACTIVE COMPARATOR

Off-Pump Coronary Artery Bypass

Procedure: Off-Pump Coronary Artery Bypass

PACAB

ACTIVE COMPARATOR

Pump-Assisted Coronary Artery Bypass

Procedure: Pump-Assisted Coronary Artery Bypass

Interventions

Conventional Coronary Artery BypassPROCEDURE

Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest

CCAB
Off-Pump Coronary Artery BypassPROCEDURE

Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia

OPCAB
Pump-Assisted Coronary Artery BypassPROCEDURE

Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation

PACAB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • previous cardiac surgery
  • emergency indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery

Coswig, 06869, Germany

Location

Martin-Luther-University Halle-Wittenberg, Department of Cardiothoracic Surgery

Halle, 06120, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Coronary Artery Bypass, Off-Pump

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Artery BypassMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Jochen Boergermann, MD

    Martin-Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

  • Rolf E Silber, MD

    Martin-Luther-University Halle-Wittenberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 21, 2009

Study Start

January 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2010

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

DE(2)