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Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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
Last updated: May 19, 2008

Page last updated: August 23, 2015

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