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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209053
• Other study ID #: 0517-1999
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: October 14, 2013
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: October 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary Artery Bypass

Locations

Country	Name	City	State
United States	Emory Healthcare/EmoryUniversity	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Boston Scientific Corporation, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No