Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00289367
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2006-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-19', 'studyFirstSubmitDate': '2006-02-07', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of atrial fibrillation', 'timeFrame': 'during hospitalization'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients requiring CABG or valve repair/replacement surgery.\n2. Patient must be able to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients less than 18 or over 85 years of age.\n2. Patients less than 50kg or greater than 120kg.\n3. Patients currently with endocrine disorders, excluding diabetes.\n4. Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.\n5. Patients currently receiving thyroid replacement therapy.\n6. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.\n7. Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.\n8. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.\n9. Patients currently in atrial fibrillation."}, 'identificationModule': {'nctId': 'NCT00289367', 'briefTitle': 'Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': '05-075'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Triiodothyronine', 'type': 'DRUG', 'description': '0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.'}, {'name': 'triiodothyronine', 'type': 'DRUG', 'description': 'IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Irwin Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thomas and Jeanne Elmezzi Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Irwin Klein', 'oldOrganization': 'North Shore University Hospital'}}}}