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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00142194
• Collaborator: (none)
• Enrollment: 47
• Locations: 2
• Duration (Months): 29
• Patients Per Site: 23.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Jun 1, 2005
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

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. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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:

• Atrial fibrillation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322
2	Crawford Long Hospital	Atlanta	Georgia	United States	30365

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Samuel C Dudley, M.D., Ph.D., Veterans Administration/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: NCT00142194
• Other Study ID Numbers: 476-2005
• First Posted: Sep 2, 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; Cardiology
• Additional relevant MeSH terms: Atrial Fibrillation; Atrial Flutter; Inflammation

Study Results

No Results Posted as of Sep 27, 2013