Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion criteria:

• Men and women, 18 years of age or older

• Patients with multi-vessel coronary artery disease

• Patients undergoing isolated valvular heart surgery (aortic/ mitral)

• Patients undergoing CABG

Exclusion Criteria:

• Patients with cardiac arrest

• Patients with ventricular fibrillation

• Patients with cardiogenic shock

• Patients requiring circulatory arrest

• Patients with known hypersensitivity to cyclosporine

• Patients with known renal failure or a GFR <50 ml/min/1.732

• Patients with liver failure

• Patients with uncontrolled hypertension

• Women who are pregnant or who are of childbearing age and not on contraception

• Patients with a serum bilirubin level greater than 3 mg/100 mL