Best Bypass Surgery (BBS) Trial - Article
Clinical Trial: Best Bypass Surgery (BBS) Trial
This study is currently recruiting patients.
|Heart Disease |
| Procedure: Coronary artery bypass grafting ||Phase III |
MedlinePlus related topics: Heart Diseases; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Secondary Outcomes: Hyper dynamic shock; Atrial fibrillation during index admission; Need for pacing > 24 hours; Renal complications, i.e., increased serum creatinine; Reoperation for bleeding during index admission; Pneumonia; Respiratory insufficiency requiring intubation > 24 hours postoperatively; 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.
Expected Total Enrollment: 330
Study start: April 2002; Expected completion: January 2008
Last follow-up: April 2007; Data entry closure: October 2007
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.
- 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.
- 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.
Location and Contact Information
Pia Hughes, PhD +45 35457171 email@example.com
Dept. Cardiothoracic Surgery, Rigshospitalet, Copenhagen, 2100, Denmark; Recruiting
Pia Hughes, Phd +45 35457171 firstname.lastname@example.org
Pia Hughes, Phd, Principal Investigator, Copenhagen Trial Unit and Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Daniel A. Steinbrüchel, Professor, Study Director, Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Christian N. Gluud, Consultant, Study Chair, Copenhagen Trial Unit, Rigshospitalet, Copenhagen
Jan K. Madsen, Consultant, Study Chair, Dept. of Cardiology, Amtssygehuset i Gentofte, Copenhagen
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 18, 2005
ClinicalTrials.gov Identifier: NCT00120991
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-07-26