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Coronary Artery Bypass GraftingPhase 3NCT00999089

Arrested Versus Beating Heart Techniques in Coronary Revascularisation

A Phase 3 study testing Conventional Coronary Artery Bypass, Off-Pump Coronary Artery Bypass and Pump-Assisted Coronary Artery Bypass in people with Coronary Artery Bypass Grafting, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Bypass Grafting
What is being tested?
Conventional Coronary Artery Bypass, Off-Pump Coronary Artery Bypass and Pump-Assisted Coronary Artery Bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
616 participants
Where
2 sitesGermany
Study dates
Jan 2003to Sep 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • previous cardiac surgery
  • emergency indications

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Heart Center Coswig, Department of Cardiothoracic and Vascular Surgery

    Coswig, 06869

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

    Halle, 06120

Other trials in Germany

About this study

Official title: 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.

Being tested
Conventional Coronary Artery Bypass, Off-Pump Coronary Artery Bypass, Pump-Assisted Coronary Artery Bypass
Keywords
Coronary disease, Coronary artery bypass grafting, Cardiopulmonary bypass, Extracorporeal circulation, Cardioplegia, Off pump
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Coronary Artery BypassProcedure or surgery

    Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest

  • Off-Pump Coronary Artery BypassProcedure or surgery

    Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia

  • Pump-Assisted Coronary Artery BypassProcedure or surgery

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

Study groups in NCT00999089
Study groupRoleWhat they receive
CCABActive comparatorConventional Coronary Artery Bypass
Receives: Procedure: Conventional Coronary Artery Bypass
OPCABActive comparatorOff-Pump Coronary Artery Bypass
Receives: Procedure: Off-Pump Coronary Artery Bypass
PACABActive comparatorPump-Assisted Coronary Artery Bypass
Receives: Procedure: Pump-Assisted Coronary Artery Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 1, 6, 12, 24, 48 month

  2. Myocardial infarction

    Measured: 1, 6, 12, 24, 48 month

  3. Stroke

    Measured: 1, 6, 12, 24, 48 month

  4. Low-output syndrome

    Measured: in hospital

  5. duration of ventilation >= 24h

    Measured: in hospital

  6. New requirement of hemodialysis

    Measured: in hospital

Secondary outcomes (3)

  1. Completeness of revascularization

    Measured: in hospital

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

    Measured: 1, 6, 12, 24, 48 month

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

    Measured: in hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2009 (estimated)
  2. Study startJan 2003
  3. Primary completionSep 2006
  4. Study completionSep 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00999089
Sponsor's protocol ID
3CAB-STUDY
Status last verified
Oct 2009
First submitted
19 Oct 2009
Last updated
21 Oct 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conventional Coronary Artery Bypass, Off-Pump Coronary Artery Bypass and Pump-Assisted Coronary Artery Bypass in people with Coronary Artery Bypass Grafting, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 1, 6, 12, 24, 48 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00999089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2009.

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