Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00280163 |
| Other study ID # |
0506010 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 18, 2006 |
| Last updated |
February 11, 2016 |
| Start date |
November 2005 |
| Est. completion date |
February 2011 |
Study information
| Verified date |
February 2016 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Observational
|
Clinical Trial 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.
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.
