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

This study is currently recruiting participants.
Verified by Emory University, April 2007

Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00142194
  Purpose

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 Phase
Atrial Fibrillation
Inflammation
Atrial Flutter
Phase I

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

MedlinePlus related topics:   Stress   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Case Control, Retrospective/Prospective Study

Further study details as provided by Emory University:

Estimated Enrollment:   50
Study Start Date:   June 2005
Estimated Study Completion Date:   June 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Atrial fibrillation
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142194

Contacts
Contact: Jose R. Cuellar, Coordinator     404-278-9774     jcuella@emory.edu    
Contact: Irfan Shukrullah, Coordinator     404-778-5937     ishukru@emory.edu    

Locations
United States, Georgia
Emory University Hospital     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: Irfan Shukrullah     404-727-2486     ishukru@emory.edu    
      Contact: Omar H Bhatti     404-376-2810     omarhbhatti@hotmail.com    
Crawford Long Hospital     Recruiting
      Atlanta, Georgia, United States, 30365
      Contact: Jose R Cuellar     404-278-9774     jcuella@emory.edu    
      Contact: Irfan Shukrullah     404-727-2486     ishukru@emory.edu    

Sponsors and Collaborators
Emory University

Investigators
Principal Investigator:     Samuel C Dudley, M.D., Ph.D.     Veterans Administration/Emory University    
  More Information


Study ID Numbers:   476-2005
First Received:   August 31, 2005
Last Updated:   April 16, 2007
ClinicalTrials.gov Identifier:   NCT00142194
Health Authority:   United States: Institutional Review Board

Keywords provided by Emory University:
Atrial Fibrillation  
Oxidative stress  
Cardiology  

Study placed in the following topic categories:
Heart Diseases
Stress
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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