A Retrospective Study of the Role of Thiazolidinediones to Reduce the Incidence of Atrial Arrhythmias
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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: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Retrospective Study of the Role of Thiazolidinediones to Reduce the Incidence of Atrial Arrhythmias in Patients After Cardiac Surgery |
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Georgia | |
| Emory University Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Emory Crawford Long Hospital | |
| Atlanta, Georgia, United States, 30365 | |
| Veteran Administration Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Principal Investigator: | Samuel C. Dudley, Jr., MD, PhD | Veteran Administration Medical Center/Emory University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00321204 History of Changes |
| Other Study ID Numbers: | 1308-2005 |
| Study First Received: | May 1, 2006 |
| Last Updated: | May 27, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Atrial Fibrillation Atrial Flutter Cardiac Surgery Thiazolidinediones |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Fibrillation Atrial Premature Complexes Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cardiac Complexes, Premature 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013