Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

This study is currently recruiting participants.

Verified September 2011 by Yonsei University

First Received on June 29, 2010. Last Updated on September 22, 2011 History of Changes

Sponsor:	Yonsei University
Information provided by (Responsible Party):	Yong-Sun Choi, Yonsei University
ClinicalTrials.gov Identifier:	NCT01153360

Purpose

This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. It is hypothesised the oral T3 will decrease the incidence of atrial fibrillation after surgery for patients.

Condition	Intervention
Coronary Artery Occlusive Disease	Drug: liothyronine sodium Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Coronary Artery Bypass Surgery

Drug Information available for: Liothyronine sodium Cyanocobalamin Liothyronine Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

incidence of atrial fibrillation [ Time Frame: for 6 days after surgery ] [ Designated as safety issue: No ]
reduction of incidence of atrial fibrillation difference of hemodynamic performance and myocardial injury between the groups

Secondary Outcome Measures:

difference of hemodynamic performance and myocardial injury [ Time Frame: during surgery and 24 hr after surgery ] [ Designated as safety issue: No ]
difference of hemodynamic performance and myocardial injury between the groups

Estimated Enrollment:	96
Study Start Date:	June 2010
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T3 triiodothyronine	Drug: liothyronine sodium liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
Active Comparator: cyanocobalamin vitamin B12	Drug: placebo vitamin B12

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are undergoing Off-pump coronary artery bypass graft

Exclusion Criteria:

No normal sinus rhythm,
History of thyroid disease
Abnormal thyroid hormone
Renal dysfunction
Hepatic dysfunction
LVEF <30%
Recent MI
Active infection 1~15

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153360

Contacts

Contact: Yong-Sun Choi, MD, Ph.D	82-2-361-5847
Contact: Jong-Wook Song, MD

Locations

Korea, Republic of
Severance Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Yong-Sun Choi, MD, Ph.D

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator:

Yong-Sun Choi, MD, Ph.D

Anesthesiology & Pain Medicine, Severance Hospital

More Information

No publications provided

Responsible Party:	Yong-Sun Choi, assistant professor, Yonsei University
ClinicalTrials.gov Identifier:	NCT01153360 History of Changes
Other Study ID Numbers:	4-2010-0086
Study First Received:	June 29, 2010
Last Updated:	September 22, 2011
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012