Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

Condition(s) targeted: Cardiac Surgical Procedures

Intervention: cyclosporine (Drug); saline solution (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Jon-Cecil M Walkes, MD, Principal Investigator, Affiliation: University of Texas Medical School Houston
Heinrich Taegtmeyer, MD, Study Director, Affiliation: University of Texas Medical School Houston
George K Goodrick, PhD, Study Chair, Affiliation: University of Texas Medical School Houston

Overall contact:
George K Goodrick, PhD, Phone: 7134865131, Email: george.k.goodrick@uth.tmc.edu

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.

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Length of Stay (LOS)

Secondary outcome:

Left Ventricular Ejection Fraction (TTE)

Cardiac Index

SVO2

Systemic Vascular Resistance (SVR)

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

George K Goodrick, PhD, Phone: 7134865131, Email: george.k.goodrick@uth.tmc.edu

University of Texas Medical School Houston, Houston, Texas 77030, United States; Recruiting
Jon-Cecil M Walkes, MD, Phone: 713-486-5100, Email: jon-cecil.m.walkes@uth.tmc.edu
George K Goodrick, PhD, Phone: 713 485 5131, Email: george.k.goodrick@uth.tmc.edu
Jon-Cecil M Walkes, MD, Principal Investigator

Starting date: April 2010
Last updated: April 12, 2010