Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248274
Status:
TERMINATED
Last Update Posted:
2011-11-22
First Post:
2005-11-02
Brief Title:
Atrial Tissue Banking Atrial Tissue Obtained From Patients Undergoing Heart Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Assessment of Atrial Tissue Obtained From Patients Undergoing Heart Surgery
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Staffing and departmental changes at our site made it difficult to enroll subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 patients 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 andor 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 structurefunction obtained by examining preoperative tests performed for standard indications and the incidence of postoperative AF as a first arrhythmia diagnosis
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 patients 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 andor 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 structurefunction obtained by examining preoperative tests performed for standard indications and the incidence of postoperative AF as a first arrhythmia diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None