Markers of Oxidative Stress Present in Left Atrial Appendage Tissue in Patients With Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243802
Recruitment Status : Terminated (Terminated.)
First Posted : October 25, 2005
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University

Brief Summary:
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 or disease
Atrial Fibrillation Atrial Flutter Inflammation

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.

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Markers of Oxidative Stress Present in Left Atrial Appendage Tissue From Subjects With and Without Atrial Fibrillation
Study Start Date : May 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Oxidative Stress [ Time Frame: 1 year ]
    Increased oxidative stress and increased evidence of blood clotting.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and females between 18 and 65 years of age who have irregular heart beats coming from the upper chamber of the heart (atrial fibrillation).

Inclusion Criteria:

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

Exclusion Criteria:

  • Younger than 18 and older than 65 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243802

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

Responsible Party: Samuel C. Dudley, Jr., Principal Investigator, Emory University Identifier: NCT00243802     History of Changes
Other Study ID Numbers: 310-2005
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013

Keywords provided by Samuel C. Dudley, Jr., Emory University:
Atrial Fibrillation
Oxidative Stress
Atrial Flutter

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