Clinical trial NCT00990795: Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Official title: A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cardiac Surgical Procedures
Keywords: open heart surgery
cyclosporine
myocardial protection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: Length of Stay (LOS)
timeFrame: postoperative to 30 days
Secondary outcomes:
measure: Left Ventricular Ejection Fraction (TTE)
timeFrame: postoperative
measure: Cardiac Index
timeFrame: postoperative
measure: SVO2
timeFrame: Postoperative
measure: Systemic Vascular Resistance (SVR)
timeFrame: postoperative
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School Houston
state: Texas
Study officials:
affiliation: University of Texas Medical School Houston
name: Jon-Cecil M Walkes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical School Houston
name: Heinrich Taegtmeyer, MD
role: STUDY_DIRECTOR
affiliation: University of Texas Medical School Houston
name: George K Goodrick, PhD
role: STUDY_CHAIR
References: