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

This study has been terminated.
(Staffing and departmental changes at our site made it difficult to enroll subjects.)
Sponsor:
Collaborator:
EP Research funds
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00248274
First received: November 2, 2005
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Atrial Tissue Obtained From Patients Undergoing Heart Surgery

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA
  1. myocardial tissue
  2. DNA

Enrollment: 300
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects are patients of UPMC Cardiothoracic Surgery who are having standard of care CT surgery.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248274

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
EP Research funds
Investigators
Principal Investigator: David S. Schwartzman, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00248274     History of Changes
Other Study ID Numbers: 0406094
Study First Received: November 2, 2005
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
atrial fibrillation
genetics

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014