Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209053
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2005-09-14
Brief Title:
SMART Trial Longitudinal Follow-UpOff-Pump Versus On-Pump Coronary Artery Bypass Surgery
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Prospective Randomized Comparison of Graft Patency and Clinical Outcomes After Coronary Bypass Surgery Performed With and Without the Use of Cardiopulmonary BypassLongitudinal Follow-Up
Status:
COMPLETED
Status Verified Date:
2013-10
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:
None
Brief Summary:
The purpose of this study is to determine completeness of revascularization graft patency clinical outcomes health-related quality of life and costs in 200 initial trial participants at 5 years post surgery who had heart bypass surgery with heart-lung bypass on-pump or without heart-lung bypass off-pump The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery
Detailed Description:
The Surgical Management of Arterial Revascularization Therapies SMART trial is a randomized controlled double blinded trial designed to compare completeness of revascularization graft patency clinical outcomes health-related quality of life and costs in 200 unselected patients referred for elective isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass These patients were enrolled between March 2000 to August 2001
The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass OPCABare no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass CABGCPBafter 5 years of follow-up non-inferiority hypothesis
The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at 5 years
1 Neurocognitive Function
2 Strokecerebral injury
3 Health-related quality of life
4 Myocardial perfusion and ischemia
5 Major Adverse Cardiac Events MACE
6 Cardiac Functional Status
7 Incidence and severity of angina
8 All cause mortality and cardiovascular mortality
9 Cost of hospital re-admissions since 1 year follow-up
The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass OPCABare no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass CABGCPBafter 5 years of follow-up non-inferiority hypothesis
The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at 5 years
1 Neurocognitive Function
2 Strokecerebral injury
3 Health-related quality of life
4 Myocardial perfusion and ischemia
5 Major Adverse Cardiac Events MACE
6 Cardiac Functional Status
7 Incidence and severity of angina
8 All cause mortality and cardiovascular mortality
9 Cost of hospital re-admissions since 1 year follow-up
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