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
|Condition or disease||Phase|
|Atrial Fibrillation Inflammation Atrial Flutter||Phase 1|
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 Type :||Observational|
|Actual Enrollment :||47 participants|
|Observational Model:||Case Control|
|Official Title:||Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation|
|Study Start Date :||June 2005|
|Primary Completion Date :||November 2007|
|Study Completion Date :||November 2007|
- 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 ]
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
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Crawford Long Hospital|
|Atlanta, Georgia, United States, 30365|
|Principal Investigator:||Samuel C Dudley, M.D., Ph.D.||Veterans Administration/Emory University|