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Genomics and Postoperative Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00280163
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

This research study is done to find out if genetic make up of a person plays a role in complications and recovery after the Coronary Artery Bypass Graft (CABG) operation.

As you may be aware, the DNA (Deoxyribonucleic acid) is a chemical in our body that carries the genetic information. There are common but very small variations (polymorphisms) that occur in DNA. We would like to find out if these common variations put a person at increased risk for developing complications- especially rapid irregular heart beat after the CABG operation.

Condition or disease
Postoperative Atrial Fibrillation, Genomics

Detailed Description:

Postoperative Atrial Fibrillation has been shown to increase the length of hospital stay; markedly increase cost and potentially increases the incidence of post-operative stroke. Nationally, postoperative atrial fibrillation (AF) is a common complication of cardiac surgery, occurring in 25% to 40% of patients and total costs of billions of dollars per year to treat At University of Pittsburgh Presbyterian University Hospital, over the past few years, our patients experience AF in the postoperative period at an average rate of 30% -40%. The incidence of postoperative AF increases with the age of the patient. The average age of the patient that undergoes CABG surgery has been on the increase due to the improved longevity of the population.

Coronary artery bypass grafting is associated with systemic inflammatory response. There have been studies performed to assess the relationship of genetic polymorphisms that could affect the expression of cytokines such as interleukin 6 (IL-6). Interleukin 6 is a pro-inflammatory cytokine and major mediator of acute phase response. The correlation between the -174 G/C polymorphism and the high production of IL-6 has enabled some investigators to anticipate and treat the patients prophylactically to reduce the IL-6 levels. 8

It has been suggested that inflammation can have a role in the development of atrial arrhythmias after cardiac surgery and that genetic predisposition to develop postoperative complications exists. There have been studies performed in Europe to ascertain this association and it has been found that the -174G/C Interleukin-6 promoter gene variant appears to modulate the inflammatory response to surgery and to influence the development of postoperative AF. These data suggest an inflammatory component of postoperative atrial arrhythmias and a genetic predisposition to this complication , this polymorphism has also been correlated with the development of postoperative renal and pulmonary complications.

Enrolled patients will have a single blood sample of 6 ml drawn prior to their CABG surgery.

Any personal identifiers on the blood sample tube will be removed and code numbers specific for this research study will be affixed on to the samples by the research coordinator before the samples are sent to the Genomics laboratory for analyses.

Study Design

Study Type : Observational
Actual Enrollment : 336 participants
Time Perspective: Prospective
Official Title: Genomics and Postoperative Atrial Fibrillation
Study Start Date : November 2005
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients about to undergo or have undergone Coronary Artery Bypass surgery

Inclusion Criteria:

  • Patients that are about to have a Coronary Artery Bypass Grafting Surgery done.

Exclusion Criteria:

  • Inability or unwilling to provide an informed consent to the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280163

United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Lawrence Wei, MD University of Pittsburgh
More Information

Responsible Party: Lawrence Wei, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00280163     History of Changes
Other Study ID Numbers: 0506010
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by Lawrence Wei, University of Pittsburgh:
Genomics, cardiac surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes