Status:
TERMINATED
Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Cardiac Surgical Procedures
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 diminishin...
Detailed Description
The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00990795
Start Date
April 1 2010
End Date
October 1 2010
Last Update
November 2 2010
Active Locations (1)
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1
University of Texas Medical School Houston
Houston, Texas, United States, 77030