Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

Phase 1

Terminated

• Conditions: Cardiac Surgical Procedures
• Interventions: Drug: saline solution; Drug: cyclosporine

• Registration Number: NCT00990795
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Study Timeline

• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Study Start: 2010-04
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	saline solution	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.
Cyclosporine	cyclosporine	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.

Primary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	postoperative to 30 days

Secondary Outcome Measures

Name	Time	Method
Cardiac Index	postoperative
SVO2	Postoperative
Left Ventricular Ejection Fraction (TTE)	postoperative
Systemic Vascular Resistance (SVR)	postoperative

Trial Locations

Locations (1)

University of Texas Medical School Houston; 🇺🇸 Houston, Texas, United States