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

Phase 1
Completed
Conditions
Atrial Fibrillation
Registration Number
NCT00289367
Lead Sponsor
Northwell Health
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
280
Inclusion Criteria
  1. Patients requiring CABG or valve repair/replacement surgery.
  2. Patient must be able to provide informed consent.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
incidence of atrial fibrillationduring hospitalization
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

North Shore University Hospital

🇺🇸

Manhasset, New York, United States

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