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Heart DiseasePhase 3NCT00120991

Best Bypass Surgery (BBS) Trial

A Phase 3 study testing Coronary artery bypass grafting in people with Heart Disease and Cardiovascular Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

There is evidence linking cardiopulmonary bypass to negative side effects when used for coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the use of cardiopulmonary bypass. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Heart Disease, Cardiovascular Disease
What is being tested?
Coronary artery bypass grafting
Type of treatment
Surgery or procedure
How many people
341 participants
Where
1 siteDenmark
Study dates
Apr 2002to Jul 2008
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Known ischemic three vessel heart disease affecting one of the marginal coronary arteries
  • Age > 54 years
  • Scheduled for elective or subacute CABG
  • EuroSCORE > 4 and < 17
  • The patient has signed written informed consent before randomization and surgery.

Who cannot join

  • Previous heart surgery
  • Ejection fraction < 30 %
  • Unstable preoperative condition, i.e., continuous infusion of inotropics on the day of the operation
  • Patient unable to give informed consent.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Dept. Cardiothoracic Surgery, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting on Postoperative Mortality and Morbidity, A Randomized Clinical Trial

There is evidence linking cardiopulmonary bypass to negative side effects when used for coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the use of cardiopulmonary bypass. The purpose of this study is to determine the positive and negative effects of coronary artery bypass grafting with or without the use of cardiopulmonary bypass. The patients will be followed at least one year after surgery.

Read the detailed description

Objectives:

To evaluate the beneficial and harmful effects of off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CCABG) using a heart- and lung machine in patients with three-vessel coronary artery disease.

Trial population:

Consecutive patients > 54 years of age with three-vessel coronary artery disease with EuroSCORE of 5-16 undergoing elective or sub-acute coronary artery bypass grafting, giving written informed consent, and where randomisation can be accomplished preoperatively. The study will include 330 patients.

Trial design:

The Best Bypass Surgery Trial (BBS Trial) is a randomised trial. Patients will be randomised to one of two groups. The randomisation will be 1:1, in blocks, stratified by gender, age (55 to 65 years; > 65 years), diabetes mellitus, and EuroSCORE (5-7; 8-10; 11-13; 14-16). The patients will be randomised to OPCAB surgery or CCABG surgery.

The interventions:

In the OPCAB group, the revascularization procedure will be performed on the beating heart with a stabilizer to demobilize the target coronary arteries. When access is needed for posterior coronary arteries a suction device will lift the heart. In the CCABG group, the revascularization procedure will be performed with the use of a heart- and lung machine in normothermia, aortic cross clamp, and with cold cardioplegic arrest. In both groups, the left internal mammary artery and saphenous vein grafts are standard graft material.

Outcome measures:

The aim of the study is to examine the value of OPCAB revascularization compared to CCABG revascularization on the following outcome measures:

  • Primary: The composite outcome measure of mortality (of all causes), acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, or major neurological deficit.
  • Secondary: Hyper dynamic shock; atrial fibrillation, respiratory insufficiency requiring intubation >24 hours , need for pacing > 1 day due to 2º AV-blockage or nodal rhythm; renal complications, i.e., serum creatinine > 200 μmol/l, or need for acute dialysis; re-operation for bleeding, pneumonia; serious adverse events; duration of stay in intensive care unit; duration of stay in the hospital; quality of life after 3 and 12 month; graft patency at one year postoperatively defined by coronary angiography. In addition, cognitive function will be assessed after three and 12 months in the first 120 patients randomized.
Being tested
Coronary artery bypass grafting
Keywords
Coronary artery bypass grafting, OPCAB
Medical subject headings
Heart Diseases, Cardiovascular Diseases

What participants receive

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

  • Coronary artery bypass graftingProcedure or surgery

What is being measured

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

  1. All cause mortality

    Measured: Short and long term

  2. Acute myocardial infarction

  3. Cardiac arrest with successful resuscitation

  4. Low cardiac output syndrome/cardiogenic shock

  5. Stroke

  6. Need for renewed cardiac revascularization procedure

Secondary outcomes (12)

  1. Hyper dynamic shock

  2. Atrial fibrillation during index admission

  3. Need for pacing > 24 hours

  4. Renal complications, i.e., increased serum creatinine

  5. Reoperation for bleeding during index admission

  6. Pneumonia

  7. Respiratory insufficiency requiring intubation > 24 hours postoperatively

  8. Serious adverse events

  9. Duration of stay in intensive care unit

  10. Duration of stay in the hospital

  11. Quality of life after 3 and 12 month

  12. Graft patency at one year postoperatively defined by coronary angiography.

Timeline

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

  1. First posted19 Jul 2005 (estimated)
  2. Study startApr 2002
  3. Primary completionMar 2006
  4. Study completionJul 2008 (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
Outcomes assessor
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120991
Sponsor's protocol ID
2001-11-DP-83-RKF-22
Status last verified
Feb 2008
First submitted
8 Jul 2005
Last updated
3 Mar 2008
Results posted
No

Publications

  • Moller CH, Perko MJ, Lund JT, Andersen LW, Kelbaek H, Madsen JK, Winkel P, Gluud C, Steinbruchel DA. Three-year follow-up in a subset of high-risk patients randomly assigned to off-pump versus on-pump coronary artery bypass surgery: the Best Bypass Surgery trial. Heart. 2011 Jun;97(11):907-13. doi: 10.1136/hrt.2010.211680. Epub 2011 Mar 17.

    PubMed 21415073

  • Moller CH, Perko MJ, Lund JT, Andersen LW, Kelbaek H, Madsen JK, Winkel P, Gluud C, Steinbruchel DA. No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial. Circulation. 2010 Feb 2;121(4):498-504. doi: 10.1161/CIRCULATIONAHA.109.880443. Epub 2010 Jan 18.

    PubMed 20083683

  • Jensen BO, Rasmussen LS, Steinbruchel DA. Cognitive outcomes in elderly high-risk patients 1 year after off-pump versus on-pump coronary artery bypass grafting. A randomized trial. Eur J Cardiothorac Surg. 2008 Nov;34(5):1016-21. doi: 10.1016/j.ejcts.2008.07.053. Epub 2008 Sep 7.

    PubMed 18778948

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coronary artery bypass grafting in people with Heart Disease and Cardiovascular Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 5 inclusion and 4 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 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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: Short and long term). 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 NCT00120991, which also lists 3 linked publications.

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 3 Mar 2008.

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