NCT00990795

Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 isolated valvular or coronary artery bypass procedures. The research question is: Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of: * Transthoracic ECHO (TTE) assessment of ejection fraction * Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR) * Length of stay * 30-d mortality * Angina Scale * SF-36 measure of quality of life * Measures associated with myocardial function: 1. Cardiac Index 2. Blood glucose level 3. Serum Troponin I level 4. Free Fatty Acid levels 5. Serum CPK-MB levels 6. Serum phosphoratase levels

Conditions

• Cardiac Surgical Procedures

Interventions

Type	Name	Description
DRUG	cyclosporine	Cyclosporine Patients will receive a dose of cyclosporine just after they are heparinized. They will receive 2.5 mg of cyclosporine (Sandimmune, Novartis) per kilogram of body weight. It will be injected into a central venous line at the time the central venous line is inserted by the anesthesia team.
DRUG	saline solution	Placebo Group: Patients will undergo the cardiac surgery procedures using standard technique. They will have ischemic arrest of the heart with cold blood cardioplegia using standardized methods of myocardial protection or off-pump CABG. The patients in the placebo group will receive a volumetrically equivalent dose of normal saline to the cyclosporine dose.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-10-07
• Last updated: 2010-11-02

Locations

1 site across 1 country: United States