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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Boston Scientific Corporation
Information provided by (Responsible Party):
John Puskas, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00209053
First received: September 14, 2005
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Coronary Artery Bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209053

Locations
United States, Georgia
Emory Healthcare/EmoryUniversity
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Medtronic
Boston Scientific Corporation
Investigators
Principal Investigator: John D Puskas, M.D. Emory University
  More Information

No publications provided

Responsible Party: John Puskas, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209053     History of Changes
Other Study ID Numbers: 0517-1999
Study First Received: September 14, 2005
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014