Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Cardiac Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT00990795
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 72
- Starts
- 2010-04-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2010-11-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas Medical School Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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