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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University
ClinicalTrials.gov Identifier:
NCT00142194
First received: August 31, 2005
Last updated: September 26, 2013
Last verified: September 2013

August 31, 2005
September 26, 2013
June 2005
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00142194 on ClinicalTrials.gov Archive Site
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Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation
Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

Patients older than 18 years with or without permanent or persistent atrial fibrillation.

  • Atrial Fibrillation
  • Inflammation
  • Atrial Flutter
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Neuman RB, Bloom HL, Shukrullah I, Darrow LA, Kleinbaum D, Jones DP, Dudley SC Jr. Oxidative stress markers are associated with persistent atrial fibrillation. Clin Chem. 2007 Sep;53(9):1652-7. Epub 2007 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142194
476-2005
No
Samuel C. Dudley, Jr., Emory University
Emory University
Not Provided
Principal Investigator: Samuel C Dudley, M.D., Ph.D. Veterans Administration/Emory University
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP