Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Triiodothyronine (Drug); triiodothyronine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Irwin Klein, MD, Principal Investigator, Affiliation: North Shore University Hospital
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.
Clinical Details
Official title: Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: incidence of atrial fibrillation
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients requiring CABG or valve repair/replacement surgery.
2. Patient must be able to provide informed consent.
Exclusion Criteria:
1. Patients less than 18 or over 85 years of age.
2. Patients less than 50kg or greater than 120kg.
3. Patients currently with endocrine disorders, excluding diabetes.
4. Patients currently with thyroid dysfunction (e. g., hyper- hyperthyroidism, goiter,
Grave's disease), myxedema, or myxedema coma, even if treated.
5. Patients currently receiving thyroid replacement therapy.
6. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine
supplementation.
7. Patients who have received any investigational drugs within the previous one month or
five half-lives of the drug.
8. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing
potential.
9. Patients currently in atrial fibrillation.
Locations and Contacts
North Shore University Hospital, Manhasset, New York 11030, United States
Additional Information
Starting date: February 2006
Ending date: May 2008
Last updated: May 19, 2008
|
