SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00209053|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Coronary Artery Bypass||Not Applicable|
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 (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after > 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:
- Neurocognitive Function
- Stroke/cerebral injury
- Health-related quality of life
- Myocardial perfusion and ischemia
- Major Adverse Cardiac Events (MACE)
- Cardiac Functional Status
- Incidence and severity of angina
- All cause mortality and cardiovascular mortality
- Cost of hospital re-admissions since 1 year follow-up
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Comparison of Graft Patency and Clinical Outcomes After Coronary Bypass Surgery Performed With and Without the Use of Cardiopulmonary Bypass:Longitudinal Follow-Up|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: Off Pump CABG
CABG without cardiopulmonary bypass.
Procedure: Coronary Artery Bypass
Active Comparator: On-Pump CABG
CABG with cardiopulmonary bypass.
Procedure: Coronary Artery Bypass
- after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography. [ Time Frame: 8 year follow-up ]
- Secondary outcomes will be measured by; a battery of neuropsychological tests, MRI, NIH stroke scale, questionnaires, cardiac PET scanning, NYHA and CCS classifications and Medicare DRG's. [ Time Frame: 8 year follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209053
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||John D Puskas, M.D.||Emory University|