The Assessment of Oxidative Stress Markers and the Development of Atrial Fibrillation After Cardiac Surgery (POAF)

This study has been terminated.
(Insufficient patient volume)
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00846534
First received: January 14, 2009
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post operative atrial fibrillation
To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846534

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Samuel C Dudley, MD. PhD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Samuel C. Dudley, Professor, 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: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
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 22, 2014