Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Not Recruiting

Trial ID: NCT00032630

Purpose

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.

Official Title

CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - Elective or Urgent CABG

   - CABG only procedure to be performed

Exclusion Criteria:

   - 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

Intervention(s):

procedure: Coronary artery bypass - on-pump

procedure: Coronary artery bypass - off-pump

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305