Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery (CYCLO1)

This study has been terminated.
(PI left institution.)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00990795
First received: October 5, 2009
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Cardiac Surgical Procedures
Drug: cyclosporine
Drug: saline solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Length of Stay (LOS) [ Time Frame: postoperative to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left Ventricular Ejection Fraction (TTE) [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • Cardiac Index [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • SVO2 [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
  • Systemic Vascular Resistance (SVR) [ Time Frame: postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Placebo Comparator: Placebo
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
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990795

Locations
United States, Texas
University of Texas Medical School Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jon-Cecil M Walkes, MD University of Texas Medical School Houston
Study Director: Heinrich Taegtmeyer, MD University of Texas Medical School Houston
Study Chair: George K Goodrick, PhD University of Texas Medical School Houston
  More Information

No publications provided

Responsible Party: Jon-Cecil Walkes, MD, University of Texas Medical School Houston
ClinicalTrials.gov Identifier: NCT00990795     History of Changes
Other Study ID Numbers: CYCLO1
Study First Received: October 5, 2009
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
open heart surgery
cyclosporine
myocardial protection

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014