Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Completed · Phase 3

Conditions studied: Ischemic Heart Disease

In brief

Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest ("on-pump") and the other without CPB on a beating heart ("off-pump"). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.

Key facts

Study ID

NCT00032630

Run by

US Department of Veterans Affairs

People needed

2203

Starts

2002-04-01

Expected to finish

2008-04-01

Last updated by the study team

2014-05-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Elective or Urgent CABG
• CABG only procedure to be performed

You may not qualify if…

• Patient's surgeon is not a participant that meets study off-pup criteria
• Valve or Valve/CABG procedure
• Emergent, hemodynamically unstable, or in cardiogenic shock preoperatively
• Moderate, moderate, to severe, or severe valvular disease
• Enrolled in another therapeutic or interventional study
• Majority of diffusely diseased distal vessels
• Clinical Care Team has reservations
• History of on-compliance
• Patient preference for treatment arm
• Inability to provide informed consent

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States
• VA Medical Center, San Francisco — San Francisco, California, United States
• VA Greater Los Angeles HCS, Sepulveda — Sepulveda, California, United States
• VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
• VA Medical Center, DC — Washington D.C., District of Columbia, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• VA Medical Center, Miami — Miami, Florida, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• New Mexico VA Health Care System, Albuquerque — Albuquerque, New Mexico, United States
• VA Medical Center, Asheville — Asheville, North Carolina, United States
• VA Medical Center, Durham — Durham, North Carolina, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• VA Medical Center, Portland — Portland, Oregon, United States
• VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States
• VA North Texas Health Care System, Dallas — Dallas, Texas, United States
• VA South Texas Health Care System, San Antonio — San Antonio, Texas, United States
• Zablocki VA Medical Center, Milwaukee — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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