Trial Search Results

Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

US Department of Veterans Affairs

Stanford Investigator(s):

Intervention(s):

  • Procedure: Coronary artery bypass - on-pump
  • Procedure: Coronary artery bypass - off-pump

Phase:

Phase 3

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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting