Atrial Tissue Banking: Atrial Tissue Obtained From Patients Undergoing Heart Surgery

Atrial Fibrillation Clinical Trial

Official title:

Assessment of Atrial Tissue Obtained From Patients Undergoing Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00248274
• Other study ID #: 0406094
• Status: Terminated
• Phase: N/A
• First received: November 2, 2005
• Last updated: November 21, 2011
• Start date: January 2005
• Est. completion date: January 2009

Study information

• Verified date: November 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• Microscopic histology using standard tissue stains; and

• Characterization of gene expression.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18+ years of age

• Referred for heart surgery for standard indication

• Competent to give informed consent

Exclusion Criteria:

• Inability to give informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	EP Research funds

Country where clinical trial is conducted

United States,