Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032630
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2002-03-27
Brief Title:
Outcomes Following Myocardial Revascularization On and Off Cardiopulmonary Bypass
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 517 - Outcomes Following Myocardial Revascularization On and Off Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
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:
ROOBY
Brief Summary:
Ischemic heart disease is one of the most frequent diagnoses in the VA system Moreover 5819 coronary artery bypass graft CABG-only procedures were performed in the VA in Fiscal Year FY 1999 Throughout VA and non-VA cardiac surgery programs nationwide myocardial revascularization is now being performed using two surgical techniques One technique is performed with cardiopulmonary bypass CPB usually with cardioplegic arrest on-pump and the other without CPB on a beating heart off-pump The overall purpose of this proposed randomized controlled clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft CABG-only procedures performed with a traditional median sternotomy incision upon patient clinical outcomes and resource utilization
Detailed Description:
Primary Hypotheses The study has two primary hypotheses to evaluate the impact of using an off-pump versus an on-pump surgical technique for CABG procedures One is a short term objective to assess the immediate impact of the two surgical techniques while the second assesses the long-term impact of the two techniques 1 Short-Term Null Hypothesis For patients having CABG-only procedures performed there will be no difference in the short-term composite clinical outcome 30 day death or major morbidity between patients randomized to the on-pump and off-pump procedures 2 Long-Term Null Hypothesis For patients undergoing CABG-only procedures there will be no difference in long-term clinical outcome as measured by one year mortality andor acute myocardial infarction prior to one year andor a subsequent revascularization procedure within one year between patients randomized to the on-pump and off-pump procedures
Secondary Hypotheses Major secondary objectives are to determine if there are differences in patients undergoing CABG-only procedures using the on-pump and off-pump techniques for 1 long-term completeness of revascularization 2 one year graft patency and stenosis rates as determined by angiography at one year and 3 short-term completeness of revascularization Other secondary objectives are to evaluate the two surgical techniques on 1 changes in neuropsychological function 2 traditional clinical outcomes 3 general and disease specific quality of life and 4 use of system resources
Intervention Patients requiring an elective or urgent CABG-only no other procedures to be done surgical procedure will be randomized to either the off-pump procedure or to the on-pump procedure
Primary Outcomes The short-term primary outcome measure is a composite measure of death repeat cardiac surgery new technical support cardiac arrest coma prolonged stroke andor renal failure requiring dialyses occurring within 30 days of surgery or prior to discharge whichever is latest The long-term primary outcome measure is a composite of death acute myocardial infarction andor subsequent revascularization procedure prior to one year post-surgery
Study Abstract Ischemic heart disease is one of the most frequent diagnoses in the VA system Moreover 5819 coronary artery bypass graft CABG-only procedures were performed in the VA in FY 1999 Throughout VA and non-VA cardiac surgery programs nationwide myocardial revascularization is now being performed using two surgical techniques One technique is performed with cardiopulmonary bypass CPB usually with cardioplegic arrest on-pump and the other without CPB on a beating heart off-pump The overall purpose of this proposed randomized controlled clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft CABG-only procedures performed with a traditional median sternotomy incision upon patient clinical outcomes and resource utilization
Secondary Hypotheses Major secondary objectives are to determine if there are differences in patients undergoing CABG-only procedures using the on-pump and off-pump techniques for 1 long-term completeness of revascularization 2 one year graft patency and stenosis rates as determined by angiography at one year and 3 short-term completeness of revascularization Other secondary objectives are to evaluate the two surgical techniques on 1 changes in neuropsychological function 2 traditional clinical outcomes 3 general and disease specific quality of life and 4 use of system resources
Intervention Patients requiring an elective or urgent CABG-only no other procedures to be done surgical procedure will be randomized to either the off-pump procedure or to the on-pump procedure
Primary Outcomes The short-term primary outcome measure is a composite measure of death repeat cardiac surgery new technical support cardiac arrest coma prolonged stroke andor renal failure requiring dialyses occurring within 30 days of surgery or prior to discharge whichever is latest The long-term primary outcome measure is a composite of death acute myocardial infarction andor subsequent revascularization procedure prior to one year post-surgery
Study Abstract Ischemic heart disease is one of the most frequent diagnoses in the VA system Moreover 5819 coronary artery bypass graft CABG-only procedures were performed in the VA in FY 1999 Throughout VA and non-VA cardiac surgery programs nationwide myocardial revascularization is now being performed using two surgical techniques One technique is performed with cardiopulmonary bypass CPB usually with cardioplegic arrest on-pump and the other without CPB on a beating heart off-pump The overall purpose of this proposed randomized controlled clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft CABG-only procedures performed with a traditional median sternotomy incision upon patient clinical outcomes and resource utilization
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