Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT00990795
Status:
TERMINATED
Last Update Posted:
2010-11-02
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'whyStopped': 'PI left institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2009-10-05', 'studyFirstSubmitQcDate': '2009-10-06', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay (LOS)', 'timeFrame': 'postoperative to 30 days'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction (TTE)', 'timeFrame': 'postoperative'}, {'measure': 'Cardiac Index', 'timeFrame': 'postoperative'}, {'measure': 'SVO2', 'timeFrame': 'Postoperative'}, {'measure': 'Systemic Vascular Resistance (SVR)', 'timeFrame': 'postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open heart surgery', 'cyclosporine', 'myocardial protection'], 'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe research question is:\n\nCompared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:\n\n* Transthoracic ECHO (TTE) assessment of ejection fraction\n* Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)\n* Length of stay\n* 30-d mortality\n* Angina Scale\n* SF-36 measure of quality of life\n* Measures associated with myocardial function:\n\n 1. Cardiac Index\n 2. Blood glucose level\n 3. Serum Troponin I level\n 4. Free Fatty Acid levels\n 5. Serum CPK-MB levels\n 6. Serum phosphoratase levels'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Men and women, 18 years of age or older\n* Patients with multi-vessel coronary artery disease\n* Patients undergoing isolated valvular heart surgery (aortic/ mitral)\n* Patients undergoing CABG\n\nExclusion Criteria:\n\n* Patients with cardiac arrest\n* Patients with ventricular fibrillation\n* Patients with cardiogenic shock\n* Patients requiring circulatory arrest\n* Patients with known hypersensitivity to cyclosporine\n* Patients with known renal failure or a GFR \\<50 ml/min/1.732\n* Patients with liver failure\n* Patients with uncontrolled hypertension\n* Women who are pregnant or who are of childbearing age and not on contraception\n* Patients with a serum bilirubin level greater than 3 mg/100 mL'}, 'identificationModule': {'nctId': 'NCT00990795', 'acronym': 'CYCLO1', 'briefTitle': 'Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery', 'orgStudyIdInfo': {'id': 'CYCLO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine', 'description': '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.', 'interventionNames': ['Drug: cyclosporine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: saline solution']}], 'interventions': [{'name': 'cyclosporine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Cyclosporine']}, {'name': 'saline solution', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical School Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jon-Cecil M Walkes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical School Houston'}, {'name': 'Heinrich Taegtmeyer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas Medical School Houston'}, {'name': 'George K Goodrick, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas Medical School Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jon-Cecil Walkes, MD', 'oldOrganization': 'University of Texas Medical School Houston'}}}}