SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery
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
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jan 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedOctober 16, 2013
October 1, 2013
2.2 years
September 14, 2005
October 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography.
8 year follow-up
Secondary Outcomes (1)
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.
8 year follow-up
Study Arms (2)
Off Pump CABG
EXPERIMENTALCABG without cardiopulmonary bypass.
On-Pump CABG
ACTIVE COMPARATORCABG with cardiopulmonary bypass.
Interventions
Eligibility Criteria
You may qualify if:
- Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial
You may not qualify if:
- Emergent CABG
- Required pre-operative intra-aortic balloon pump (IABP)
- Cardiogenic shock
- Evolving acute myocardial infarction
- Coronary artery targets unsuitable for off-pump bypass surgery
- Inability or unwillingness to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Medtroniccollaborator
- Boston Scientific Corporationcollaborator
Study Sites (1)
Emory Healthcare/EmoryUniversity
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Puskas, M.D.
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 21, 2005
Study Start
January 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
October 16, 2013
Record last verified: 2013-10