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Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

NCT00990795 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-11-02

No results posted yet for this study

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

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Jon-Cecil M Walkes, MD · University of Texas Medical School Houston

  • Heinrich Taegtmeyer, MD · University of Texas Medical School Houston

  • George K Goodrick, PhD · University of Texas Medical School Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990795 on ClinicalTrials.gov