Assessment of Atrial Tissue Obtained From Patients Undergoing Heart Surgery and Tissue Banking

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
David Schwartzman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01793623
First received: January 17, 2013
Last updated: January 24, 2014
Last verified: December 2013
  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).


Condition Intervention
Atrial Fibrillation
Other: atrial tissue

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Evidence of atrial physiology [ Time Frame: Visit 1, Atrial tissue sample obtained at the time of surgery ] [ Designated as safety issue: No ]
    Normally discarded atrial tissue samples will be collected at the time of cardiac surgery and microscopic histology will be performed using standard tissue stains


Secondary Outcome Measures:
  • Evidence of underlying molecular mechanisms of atrial disease [ Time Frame: Visit 1, Atrial tissue samples obtained at the time of surgery ] [ Designated as safety issue: No ]
    Normally discarded atrial tissue samples will be collected at the time of cardiac surgery and the samples will be assayed for gene expression


Biospecimen Retention:   Samples With DNA

(1) myocardial tissue (2) DNA


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
nonemergent heart surgery, atrial tissue
patients undergoing non-emergent heart surgery
Other: atrial tissue
retrieval of discarded atrial tissue

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 tissue bank 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 health information recorded that includes but is not limited to demographics, heart disease history, other past medical history, lab work,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 open heart surgery

Criteria

Inclusion Criteria:

  • 18 years or over
  • 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: NCT01793623

Contacts
Contact: David S Schwartzman, MD 412-802-3372 schwartzmand@upmc.edu
Contact: Kimberly A Veltre, MSN 412-864-1420 veltrek@upmc.edu

Locations
United States, Pennsylvania
University Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly Veltre, MSN    412-864-1420    veltrek@upmc.edu   
Contact: Dina Poole, RN    412-647-2931    pooledr@upmc.edu   
Sub-Investigator: Vinay Badhwar, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David S Schwartzman, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: David Schwartzman, Professor of Medicine, University of Pittsburgh, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01793623     History of Changes
Other Study ID Numbers: PRO12050391
Study First Received: January 17, 2013
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
atrial fibrillation
genetics
cardiac arrhythmias
heart disease

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

ClinicalTrials.gov processed this record on August 26, 2014