NCT01793623

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2016

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

January 17, 2013

Last Update Submit

March 20, 2023

Conditions

Keywords

atrial fibrillationgeneticscardiac arrhythmiasheart disease

Outcome Measures

Primary Outcomes (1)

  • Evidence of atrial physiology

    Normally discarded atrial tissue samples will be collected at the time of cardiac surgery and microscopic histology will be performed using standard tissue stains

    Visit 1, Atrial tissue sample obtained at the time of surgery

Secondary Outcomes (1)

  • Evidence of underlying molecular mechanisms of atrial disease

    Visit 1, Atrial tissue samples obtained at the time of surgery

Study Arms (1)

nonemergent heart surgery, atrial tissue

patients undergoing non-emergent heart surgery

Other: atrial tissue

Interventions

retrieval of discarded atrial tissue

nonemergent heart surgery, atrial tissue

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 open heart surgery

You may qualify if:

  • years or over
  • 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 Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Li YY, Feldman AM, Sun Y, McTiernan CF. Differential expression of tissue inhibitors of metalloproteinases in the failing human heart. Circulation. 1998 Oct 27;98(17):1728-34. doi: 10.1161/01.cir.98.17.1728.

    PMID: 9788826BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

(1) myocardial tissue (2) DNA

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yingze Zhang, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Human Genetics

Study Record Dates

First Submitted

January 17, 2013

First Posted

February 15, 2013

Study Start

December 11, 2012

Primary Completion

February 17, 2016

Study Completion

February 17, 2016

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations