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Markers of Oxidative Stress Present in Left Atrial Appendage Tissue in Patients With Atrial Fibrillation
This study has been terminated.
( The trial ended. )
First Received: October 24, 2005   Last Updated: May 27, 2008   History of Changes
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00243802
  Purpose

The purpose of the study is to look at the differences between people who have irregular heart beats coming from the upper chamber of the heart (atrial fibrillation) compared to those who do not have these irregular beats.


Condition Phase
Atrial Fibrillation
Atrial Flutter
Inflammation
Phase II

Study Type: Observational
Official Title: Comparison of Markers of Oxidative Stress Present in Left Atrial Appendage Tissue From Subjects With and Without Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 90
Study Start Date: May 2005
Study Completion Date: October 2007
Detailed Description:

Atrial fibrillation is an abnormal heart beat that starts in the upper parts of the heart and can cause stroke or death, if untreated. In general, treatments are not very effective with frequent relapses of the abnormal heart beats. One explanation for the high relapse rate is that the treatments might not address the underlying cause of atrial fibrillation.

Recently, we have found that atrial fibrillation is associated with increased oxidative stress in a particular part of the top parts of the heart, the left atrial appendage (LAA). Oxidative stress is a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart, causing them to beat abnormally.

Also, the inside of the heart becomes sticky and more likely to form blood clots. These clots, when they travel to the head, are thought to be the main cause of strokes in this condition. We have found increased oxidative stress and increased evidence of blood clotting in pig and mouse models of atrial fibrillation. We would like to see if these same findings are present in the human LAA.

In this study, we will compare blood and tissue markers of oxidative stress between patients with and without atrial fibrillation who are scheduled to undergo cardiac surgery. It is the expectation that participants with atrial fibrillation will have more abnormal markers of atrial fibrillation. This study requires participants to be seen during their routine preoperative visit, undergo a history and physical examination, give blood only once, and allow use of their discarded LAA. This tissue is routinely removed at surgery because its removal is thought to reduce the risk of strokes in patients who develop atrial fibrillation after the surgery. This happens in up to 50% of patients, thus providing the desire to remove the LAA.

  Eligibility

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

Inclusion Criteria:

  • Cases must have atrial fibrillation documented on electrocardiographic recordings at the time of enrollment

Exclusion Criteria:

  • Atrial fibrillation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243802

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Samuel C. Dudley, Jr., M.D., Ph.D. Emory University
  More Information

No publications provided

Study ID Numbers: 310-2005
Study First Received: October 24, 2005
Last Updated: May 27, 2008
ClinicalTrials.gov Identifier: NCT00243802     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Atrial Fibrillation
Oxidative Stress
Atrial Flutter

Study placed in the following topic categories:
Heart Diseases
Stress
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009