Best Bypass Surgery (BBS) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Best Cardiac Output During Cardiopulmonary Bypass

NCT01379638

Bypass Complications

COMPLETED

Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

NCT00216957

Ischemic Heart Disease

COMPLETED PHASE3

Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery

NCT03376542

Coronary Artery Disease Surgery--Complications

COMPLETED NA

SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

NCT00209053

Coronary Artery Disease

COMPLETED NA

Conservative Non-Invasive Versus Routine Invasive Management in Coronary Artery Bypass Surgery Patients with Non ST Elevation Elevation Acute Coronary Syndrome

NCT01895751

Non ST Elevation Myocardial Infarction Unstable Angina

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Disease Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary artery bypass grafting

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No