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SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209053
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 16, 2013
Sponsor:
Collaborators:
Medtronic
Boston Scientific Corporation
Information provided by (Responsible Party):
John Puskas, MD, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Coronary Artery Bypass Not Applicable

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 (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:

  1. Neurocognitive Function
  2. Stroke/cerebral 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  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. [ Time Frame: 8 year follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Georgia
Emory Healthcare/EmoryUniversity
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Medtronic
Boston Scientific Corporation
Investigators
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Principal Investigator: John D Puskas, M.D. Emory University
More Information
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Responsible Party: John Puskas, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209053    
Other Study ID Numbers: 0517-1999
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases