Status:
COMPLETED
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Thomas and Jeanne Elmezzi Foundation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients requiring CABG or valve repair/replacement surgery.
- Patient must be able to provide informed consent.
Exclusion
- Patients less than 18 or over 85 years of age.
- Patients less than 50kg or greater than 120kg.
- Patients currently with endocrine disorders, excluding diabetes.
- Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
- Patients currently receiving thyroid replacement therapy.
- Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
- Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
- Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
- Patients currently in atrial fibrillation.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00289367
Start Date
February 1 2006
End Date
May 1 2008
Last Update
May 20 2008
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030