An observational study in Atrial Fibrillation, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-22.
Sponsored by University of Pittsburgh · Observational
Over the past decade, techniques have been refined which permit an enormous amount of information relevant to disease mechanisms to be gained from the examination of heart tissue. The Cardiovascular Institute has extensive experience with these techniques, and has utilized them to examine other heart disease substrates.
In this study, the investigators propose to obtain heart tissue at the time of cardiac surgery which would otherwise be discarded. Their plan is to examine this tissue and correlate their findings with clinical data. Their hope is that the proposed study will provide insight into atrial physiology, including the molecular mechanisms underlying atrial disease and the potential development of atrial fibrillation (AF).
This will be a prospective "registry" for atrial tissue. The investigators propose an enrollment of 300 subjects, to take place at University of Pittsburgh Medical Center (UPMC) Presbyterian over a 5 year period.
Atrial fibrillation (AF), a disorder of heart rhythm, is epidemic in the United States, affecting nearly 3 million people. AF arises in a variety of settings, often in association with other cardiac disease. Demographic and clinical factors can be utilized to profile "at-risk" patients, but the predictive value of such algorithms is low. The reasons for this presumably relate to the fact that these factors are interacting with the tissue substrate in a variable way. In addition, correlations such as these provide no insight into mechanisms associated with the development of AF in patients without other known heart disease, which is commonplace.
Over the past decade, techniques have been refined which permit an enormous amount of information relevant to disease mechanisms to be gained from examination of heart tissue. The Cardiovascular Institute has extensive experience with these techniques, and has utilized them to examine other heart disease substrates.
In this study, we propose to obtain heart tissue at the time of cardiac surgery which would otherwise be discarded. Our plan is to examine this tissue and correlate our findings with clinical data. Our hope is that the proposed study will provide insight into atrial physiology, including the molecular mechanisms underlying atrial disease and the potential development of AF.
This will be a prospective "registry" for atrial tissue. We propose an enrollment of 300 subjects, to take place at UPMC Presbyterian over a 5 year period.
Subjects will be recruited from among those patients referred for non-emergent surgery on the heart for standard indications. The patient's medical record will be reviewed and information recorded that includes demographics, heart disease history, other past medical history, current lab work, current drug therapy, and all cardiac testing the patient has undergone prior to surgery. Patients undergoing surgery will have residual atrial tissue which would otherwise be discarded (related to cannulation and/or appendectomy). Thus, obtaining this tissue will have no effect on the flow, duration, or outcome of the operative procedure.
Tissue assessment will include:
Characterization of gene expression will be performed using a multiplicity of techniques which focus on DNA, RNA and proteins produced by the various cells comprising atrial tissue. Expression of a variety of genes known to be important in other cardiac diseases will be analyzed. In addition, expression of novel genes previously not known to be relevant to heart disease may be examined.
Tissue assessment data will be correlated with clinical data including preoperative AF history, demographic information, features of the medical history, details of cardiac structure/function (obtained by examining preoperative tests performed for standard indications), and the incidence of postoperative AF as a first arrhythmia diagnosis.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 300 is close to the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects are patients of UPMC Cardiothoracic Surgery who are having standard of care CT surgery.
Exclusion Criteria:
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh