Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery (CYCLO1)

The University of Texas System (UT)

Status and phase: Terminated; Phase 1

Conditions: Cardiac Surgical Procedures

Treatments: Drug: saline solution; Drug: cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT00990795

CYCLO1

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Cyclosporine

Experimental group

Description:

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.

Treatment:

Drug: cyclosporine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: saline solution