Viewing Study NCT00142194



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00142194
Status: COMPLETED
Last Update Posted: 2013-09-27
First Post: 2005-08-31

Brief Title: Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation
Sponsor: Emory University
Organization: Emory University

Study Overview

Official Title: Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation
Status: COMPLETED
Status Verified Date: 2013-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None