NCT00248274

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

4 years

First QC Date

November 2, 2005

Last Update Submit

November 21, 2011

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationgenetics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • + years of age
  • Referred for heart surgery for standard indication
  • Competent to give informed consent

You may not qualify if:

  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. myocardial tissue 2. DNA

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David S. Schwartzman, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 3, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

US(1)