Study of T3 on the Incidence of Atrial Fibrillation in Pa... | NCT00289367

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

NCT00289367

Sponsor

Northwell Health

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

280Estimated

Phase

Phase 1

Conditions

Atrial Fibrillation

Interventions

Triiodothyronine
triiodothyronine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Aug 2006Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 7, 2006

First Submission Date that Met QC Criteria

Feb 7, 2006

First Posted Date

Feb 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2008

Last Update Posted Date

May 20, 2008Estimated

Name	Class
Thomas and Jeanne Elmezzi Foundation	OTHER

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

280Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triiodothyronine	Drug	0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
triiodothyronine	Drug	IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.

Measure	Description	Time Frame
incidence of atrial fibrillation		during hospitalization

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring CABG or valve repair/replacement surgery.
Patient must be able to provide informed consent.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irwin Klein, MD	North Shore University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Shore University Hospital		Manhasset	New York	11030	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014284	Triiodothyronine

Ancestor Terms

ID	Term
D013970	Thyronines
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided