Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120991
Status:
UNKNOWN
Last Update Posted:
2008-03-03
First Post:
2005-07-08
Brief Title:
Best Bypass Surgery BBS Trial
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting on Postoperative Mortality and Morbidity A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2008-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 11 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 ie serum creatinine 200 μmoll 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
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 11 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 ie serum creatinine 200 μmoll 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None