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

NCT00846534 | Terminated

• 1 other identifier: 2007-0916
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Oxidative stress markers; Cardiac surgery; Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Baseline of oxidative stress markers prior to subjects undergoing cardiac surgery

  up to 24 hours pre-op

• To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery

  Day 1 post-op

• To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery

  When develop Atrial Fibrillation or upon discharge from hospital, usually within 1 week post-op

Study Arms (1)

Post operative atrial fibrillation

To evaluate the ability of oxidative stress markers to predict postoperative atrial fibrillation in subjects undergoing cardiac surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

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.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel C Dudley, MD. PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: February 18, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

US (2)