Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280163
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2006-01-18
Brief Title:
Genomics and Postoperative Atrial Fibrillation
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Genomics and Postoperative Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 GC 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 -174GC 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
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 GC 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 -174GC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None