Postoperative Atrial Fibrillation, GenomicsNCT00280163
Genomics and Postoperative Atrial Fibrillation
An observational study of Postoperative Atrial Fibrillation, Genomics, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Genomics
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients about to undergo or have undergone Coronary Artery Bypass surgery
Who may be able to join
- Patients that are about to have a Coronary Artery Bypass Grafting Surgery done.
Who cannot join
- Inability or unwilling to provide an informed consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Genomics, cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial Fibrillation, GenomicsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Wei, University of Pittsburgh
- Investigators
- Lawrence Wei, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280163
- Sponsor's protocol ID
- 0506010
- Status last verified
- Feb 2016
- First submitted
- 18 Jan 2006
- Last updated
- 12 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics and Postoperative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00280163
- Acronym / sponsor ID
- 0506010
- Keywords
- Genomics, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients about to undergo or have undergone Coronary Artery Bypass surgery
Key inclusion criteria (1 listed)
- Patients that are about to have a Coronary Artery Bypass Grafting Surgery done.
Key exclusion criteria (1 listed)
- Inability or unwilling to provide an informed consent to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
Related trials for Postoperative Atrial Fibrillation, Genomics
RecruitingObservational study
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Heart; Dysfunction Postoperative, Cardiac Surgery, Genetic Predisposition to Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Wei, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Atrial Fibrillation, Genomics, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.