This observational, prospective study enrolled 5436 patients scheduled to undergo cardiopulmonary bypass for coronary revascularization at 72 medical institutions among 17 countries in North and South America, Europe, the Middle East and Asia. From each institution, 100 patients were to be enrolled following a sampling scheme. The first patient was enrolled in November 1996 and the last in June 2000. Following last patient enrollment, all data fields for each patient were queried centrally for completeness and accuracy. The perioperative database was locked on October 15, 2001 with 5065 evaluable patients from 70 centers. Long term Follow up data collection is presently ongoing for 10 years.

For each enrolled patient, in-hospital data were collected from admission to discharge in a Case Report Form (CRF) with 10,403 data points, continuous hemodynamic data for 24 hours in MCMS, blood at 6 time points, and ECGs at three designated time points. With these parameters, this study has the most comprehensive data to date to comprehend the natural history and pathophysiology of serious ischemic events occurring in this patient population.

In hospital Outcomes

Primary Objectives:

• Incidence of adverse ischemic outcomes after cardiopulmonary bypass, mortality, myocardial infarction, left ventricular dysfunction, stroke, and renal dysfunction
• Use of biochemical markers to define myocardial infarctions and renal dysfunction
• Use of medical and diagnostic resources in complicated and uncomplicated patients

Secondary Objectives:

• Incidence of other morbid events, other cardiac, neurologic, pulmonary,
  gastrointestinal complications, infection, complications due to administration of
  specific drugs, i.e., Heparin, Protamine, Antifibrinolytics, etc.
• Assessment of site variability and its economic impact

Long-Term Follow Up

Primary Objectives:

• Incidence of mortality
  
• Use of medical and diagnostic resources in complicated and uncomplicated Patients
  

Secondary Objectives:

• Incidence of cardiovascular events

• Quality of life after discharge

Native American: 18
Asian: 350
African American: 122
White: 4144
Hispanic: 273
Pacific Islander: 5
Other: 38
Unknown: 115

United States 32
Europe 24*
Canada 8
Other 6**