Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

NCT00990795 | Terminated Phase 1

• 1 other identifier: CYCLO1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgical Procedures

Keywords

open heart surgery; cyclosporine; myocardial protection

Outcome Measures

Primary Outcomes (1)

• Length of Stay (LOS)

  postoperative to 30 days

Secondary Outcomes (4)

• Left Ventricular Ejection Fraction (TTE)

  postoperative

• Cardiac Index

  postoperative

• SVO2

  Postoperative

• Systemic Vascular Resistance (SVR)

  postoperative

Study Arms (2)

Cyclosporine

EXPERIMENTAL

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.

Drug: cyclosporine

Placebo

PLACEBO COMPARATOR

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.

Drug: saline solution

Interventions

cyclosporine DRUG

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.

Cyclosporine

saline solution DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Medical School Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Cyclosporine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jon-Cecil M Walkes, MD

  University of Texas Medical School Houston

  PRINCIPAL INVESTIGATOR

• Heinrich Taegtmeyer, MD

  University of Texas Medical School Houston

  STUDY DIRECTOR

• George K Goodrick, PhD

  University of Texas Medical School Houston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 2, 2010

Record last verified: 2010-11

Locations

US (1)