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Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00142194
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University

Study Description
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Brief Summary:
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, the investigators have found that atrial fibrillation is associated with increased oxidative stress. This is a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart, causing them to beat abnormally. The investigators have found increased oxidative stress in pig and mouse models of atrial fibrillation. They would like to see if oxidative stress is present in humans with atrial fibrillation. In this study, they will compare blood markers of oxidative stress between patients with and without atrial fibrillation. It is the expectation that participants with atrial fibrillation will have more abnormal blood markers of atrial fibrillation. This study requires participants to visit their doctors, undergo a history and physical examination, and give blood only once.

Condition or disease
Atrial Fibrillation Inflammation Atrial Flutter

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 stroke 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 stroke 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
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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation
Study Start Date : June 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. atrial fibrillation (irregular heart beat coming from the upper chamber of the heart). To look at the differences between people who have irregular heart beats compared to those who do not have irregular beats. Study may last up until one year. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients older than 18 years with or without permanent or persistent atrial fibrillation.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00142194


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Crawford Long Hospital
Atlanta, Georgia, United States, 30365
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Samuel C Dudley, M.D., Ph.D. Veterans Administration/Emory University
More Information
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Publications of Results:

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Responsible Party: Samuel C. Dudley, Jr., Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00142194    
Other Study ID Numbers: 476-2005
First Posted: September 2, 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
Cardiology
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Inflammation
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes