Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

Cardiac Surgical Procedures Clinical Trial

— CYCLO1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00990795
• Other study ID #: CYCLO1
• Status: Terminated
• Phase: Phase 1
• First received: October 5, 2009
• Last updated: November 1, 2010
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Intervention

Drug:
• cyclosporine
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.
• saline solution
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.

Locations

Country	Name	City	State
United States	University of Texas Medical School Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay (LOS)		postoperative to 30 days	No
Secondary	Left Ventricular Ejection Fraction (TTE)		postoperative	No
Secondary	Cardiac Index		postoperative	No
Secondary	SVO2		Postoperative	No
Secondary	Systemic Vascular Resistance (SVR)		postoperative	No