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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine | Experimental | Cyclosporine Group: 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. |
|
| Placebo | Placebo Comparator | Placebo: 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (LOS) | postoperative to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (TTE) | postoperative | |
| Cardiac Index | postoperative | |
| SVO2 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon-Cecil M Walkes, MD | University of Texas Medical School Houston | Principal Investigator |
| Heinrich Taegtmeyer, MD | University of Texas Medical School Houston | Study Director |
| George K Goodrick, PhD | University of Texas Medical School Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical School Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| saline solution | Drug | 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. |
|
| Postoperative |
| Systemic Vascular Resistance (SVR) | postoperative |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |