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

NCT ID: NCT00209053

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Off Pump CABG

CABG without cardiopulmonary bypass.

Group Type EXPERIMENTAL

Coronary Artery Bypass

Intervention Type PROCEDURE

On-Pump CABG

CABG with cardiopulmonary bypass.

Group Type ACTIVE_COMPARATOR

Coronary Artery Bypass

Intervention Type PROCEDURE

Interventions

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Coronary Artery Bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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John Puskas, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D Puskas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Healthcare/EmoryUniversity

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0517-1999

Identifier Type: -

Identifier Source: org_study_id