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

Status Completed

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.

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00209053
Study type	Interventional
Source	Emory University
Contact
Status	Completed
Phase	N/A
Start date	January 2007
Completion date	March 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms