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

Sponsor
Emory University (Other)
Overall Status
Terminated
CT.gov ID
NCT00243802
Collaborator
(none)
23
Enrollment
1
Location
33.1
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 1, 2005
    Actual Primary Completion Date :
    Feb 1, 2008
    Actual Study Completion Date :
    Feb 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Oxidative Stress [1 year]

      Increased oxidative stress and increased evidence of blood clotting.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samuel C. Dudley, Jr., Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT00243802
    Other Study ID Numbers:
    • 310-2005
    First Posted:
    Oct 25, 2005
    Last Update Posted:
    Sep 27, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Samuel C. Dudley, Jr., Principal Investigator, Emory University
    Atrial Fibrillation
    Oxidative Stress
    Atrial Flutter
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Atrial Flutter
    Inflammation

    Study Results

    No Results Posted as of Sep 27, 2013