The Assessment of Oxidative Stress Markers and the Development of Atrial Fibrillation After Cardiac Surgery (POAF)
Recruitment status was Recruiting
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The purpose of the investigators study is to investigate the correlation between naturally occurring chemicals, called reactive oxygen species (ROS), in the blood of human patients and the development of an abnormal heart rhythm, known as atrial fibrillation (AF). The development of atrial fibrillation is associated with increased medical problems like stroke. Many factors seem to cause the development of AF, and this rhythm occurs frequently after open heart surgery. When patients develop AF after cardiac surgery they are at increased risk for cognitive changes, infections, the development of kidney failure, and increased length of hospitalization. ROS are chemicals in blood and tissues that tend to cause microscopic blood vessel and heart damage. These chemicals occur naturally as the result of chemical reactions that occur in states of stress and inflammation, like tissue trauma and as the result of smoking. Patients who undergo cardiac surgery may have higher levels of ROS because of their underlying medical conditions. In addition, the organized tissue trauma that occurs in the setting of surgery may serve to increase ROS levels further. In turn, the higher ROS levels may put patients at even higher risk for the development of AF. The investigators believe that increased levels of ROS may help potentiate a patient's development of AF. Accordingly the investigators aim to measure ROS levels before and after surgery to see if there are particular levels that predict the development of this abnormal heart rhythm. By developing a better knowledge of the relationship between ROS and AF, the investigators hope to better understand another possible method of detecting patients who are at the highest risk of developing AF before it occurs after surgery. If these patients are better identified, this may eventually lead to medical treatment to prevent AF; and hopefully this will result in a decrease of the malicious effects that result from developing this abnormal heart rhythm.
Condition |
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Atrial Fibrillation |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | The Assessment of Oxidative Stress Markers and the Development of Atrial Fibrillation After Cardiac Surgery |
- Baseline of oxidative stress markers prior to subjects undergoing cardiac surgery [ Time Frame: up to 24 hours pre-op ] [ Designated as safety issue: No ]
- To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery [ Time Frame: Day 1 post-op ] [ Designated as safety issue: No ]
- To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery [ Time Frame: When develop Atrial Fibrillation or upon discharge from hospital, usually within 1 week post-op ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Approximately 10- 15 ml of blood will be drawn from subjects. Blood samples will be separated into plasma and serum to measure the oxidative stress markers.
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2010 |
Groups/Cohorts |
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Post operative atrial fibrillation
To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery.
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Show Detailed Description
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The target population of this study is all patients who will undergo cardiac surgery. There is no particular age range, but subjects less than 18 years of age will be omitted because of the rarity of AF in this population. The target number of subjects will be 100.
Inclusion Criteria:
- Age ≥18 years
- Sinus rhythm at the time of enrollment as documented by ECG, telemetry, or Holter monitoring
- Scheduled for an open heart surgery
- Able to provide informed consent
Exclusion Criteria:
- Systemic inflammatory diseases (e.g., collagen vascular diseases, infections)
- Malignant neoplasms
- Hyperthyroidism
- Uncontrolled hypertension (blood pressure > 180/100 at rest) on medications
- An illness that might result in death within 1 year
- Implanted devices for designed for active management of atrial arrhythmias by pacing or defibrillation
- Current illicit drug use
- Current ethanol abuse
- Presence of paroxysmal, persistent, or permanent atrial fibrillation at the time of enrollment
Contact: Mihai Raicu, MS | 3129961394 | mraicu@uic.edu |
Contact: Dean Ferrera, DO | 3128390745 | dferrera@uic.edu |
United States, Illinois | |
University of Illinois at Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Mihai Raicu, MS 312-996-1394 mraicu@uic.edu | |
Contact: Dean Ferrera, DO 3128390745 dferrera@uic.edu | |
Principal Investigator: Samuel C Dudley, MD,PhD | |
Advocate Christ Medical Center | Recruiting |
Oak Lawn, Illinois, United States, 60453 | |
Contact: Irfan Shukrullah, MD 708-684-6777 irfans@uic.edu | |
Sub-Investigator: Antone Tatooles, MD | |
Sub-Investigator: Paul Silverman, MD |
Principal Investigator: | Samuel C Dudley, MD. PhD | University of Illinois |
No publications provided
Responsible Party: | Dr. Samuel C. Dudely, Jr MD. PhD/ Professor of Medicine, University of Illinois at Chicago |
ClinicalTrials.gov Identifier: | NCT00846534 History of Changes |
Other Study ID Numbers: | 2007-0916 |
Study First Received: | January 14, 2009 |
Last Updated: | August 19, 2010 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Illinois:
Oxidative stress markers Cardiac surgery Atrial Fibrillation |
Additional relevant MeSH terms:
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 26, 2012