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

This study has been terminated.
(Terminated.)
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University
ClinicalTrials.gov Identifier:
NCT00243802
First received: October 24, 2005
Last updated: September 26, 2013
Last verified: September 2013
  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 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Oxidative Stress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Increased oxidative stress and increased evidence of blood clotting.


Enrollment: 23
Study Start Date: May 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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
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).

Criteria

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
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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

Responsible Party: Samuel C. Dudley, Jr., Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00243802     History of Changes
Other Study ID Numbers: 310-2005
Study First Received: October 24, 2005
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2014