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CompletedNCT00142194Updated Sep 27, 2013

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

An observational study in Atrial Fibrillation, Inflammation and Atrial Flutter, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by Emory University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Inflammation
  • Atrial Flutter

Keywords

  • Atrial Fibrillation
  • Oxidative stress
  • Cardiology
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 47 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Atrial fibrillation
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
47 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

07

Study locations

2 sites
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
  • Crawford Long Hospital
    Atlanta, Georgia 30365, United States
08

References and documents

Publications

  • 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. doi: 10.1373/clinchem.2006.083923. Epub 2007 Jun 28. PubMed 17599958 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00142194
Lead sponsor
Emory University
Responsible party
Samuel C. Dudley, Jr. (Principal Investigator, Emory University) — Principal investigator
First posted
Sep 2, 2005
Start date
Jun 2005
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Sep 27, 2013

Study contacts

Samuel C Dudley, M.D., Ph.D.
principal investigator · Veterans Administration/Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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