Genomics and Postoperative Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00280163
First received: January 18, 2006
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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
Postoperative Atrial Fibrillation, Genomics

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genomics and Postoperative Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 380
Study Start Date: November 2005
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.

  Eligibility

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

Hospital patients about to undergo or have undergone Coronary Artery Bypass surgery

Criteria

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
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: NCT00280163

Locations
United States, Pennsylvania
UPMC PUH Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sujatha Raghu, MBBS    412-647-0749    raghus@upmc.edu   
Principal Investigator: Lawrence Wei, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Lawrence Wei, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Lawrence Wei / Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00280163     History of Changes
Other Study ID Numbers: 0506010
Study First Received: January 18, 2006
Last Updated: October 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Genomics, cardiac surgery

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

ClinicalTrials.gov processed this record on September 30, 2014