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A Retrospective Study of the Role of Thiazolidinediones to Reduce the Incidence of Atrial Arrhythmias

This study has been terminated.
(Terminated: We are no longer recruiting.)
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University
ClinicalTrials.gov Identifier:
NCT00321204
First received: May 1, 2006
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

It is well known that abnormal heart beats from the top parts of the heart, atrial fibrillation (AF) and atrial flutter (Aflut), occur frequently after most types of cardiac surgeries. Postoperative AF and Aflut are associated with significant morbidity, longer hospital stay, and higher related costs. Currently therapies are marginally effective at preventing this abnormal heart beat. The incidence of abnormal heart beats after cardiac surgery seems to be a function of the amount of inflammation and oxidative stress induced. Our group and others have shown that atrial abnormal heart beats are associated with increased oxidative stress. Thiazolidinediones (TZDs) are medications used to treat diabetes. Beside their glucose lowering effects, TZDs are shown to exhibit anti-inflammatory and antioxidant properties. Therefore, we propose to retrospectively analyze the effect of pre-operative TZDs on the incidence of post-operative AF or Aflut. This study will involve retrospective chart reviews without further patient contact of all patients having undergone cardiac surgery in Emory University Hospital, Crawford Long Hospital, or the VA Medical Center from 2000 to 2005. This study is preparatory to a funding proposal for a prospective trial.


Condition Intervention Phase
Atrial Fibrillation
Procedure: TZD reducing the incidence of atrial arrhythmias
Phase 2

Study Type: Observational
Official Title: A Retrospective Study of the Role of Thiazolidinediones to Reduce the Incidence of Atrial Arrhythmias in Patients After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 600
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patient who underwent elective cardiac Surgery in the Emory University Hospital, Crawford Long Hospital, or the Va Medical Center between 2000-2005.-

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321204

Locations
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30365
Emory University Hospital
Atlanta, Georgia, United States, 30322
Veteran Administration Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Samuel C. Dudley, Jr., MD, PhD Veteran Administration Medical Center/Emory University
  More Information

No publications provided

Responsible Party: Samuel C. Dudley, Jr., Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00321204     History of Changes
Other Study ID Numbers: IRB00002175, 1308-2005
Study First Received: May 1, 2006
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Atrial Fibrillation
Atrial Flutter
Cardiac Surgery
Thiazolidinediones

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
2,4-thiazolidinedione
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014