At a glance
ClinicalIndex Comparison Record- ✓Elective or Urgent CABG (isolated procedure)
- ✕Emergent procedure, hemodynamic instability, or cardiogenic shock preoperatively
- ✕Moderate, moderate-to-severe, or severe valvular disease
- ✕Valve surgery or combined valve/CABG procedure
- ✕Majority of diffusely diseased distal vessels
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
In Brief
A Phase 3 clinical trial evaluating Coronary artery bypass - on-pump and Coronary artery bypass - off-pump for Ischemic Heart Disease. Completed, enrolled 2,203 participants across 17 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
CABG procedure performed on heart lung machine
CABG procedure performed without the use of the heart lung machine