A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease

NCT ID: NCT01194362

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2022-12-31

Brief Summary

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For this study, blood and tissue samples will be collected in order to perform genetic testing to help researchers gather information about this disease and how and why it affects some patients more than others.

Detailed Description

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The cause of bicuspid aortic valve (BAV) and its associated co morbidities is unknown. There is, however, evidence supporting a genetic cause for the BAV, Pedigree analysis of familial clustering initially directed investigators to a genetic cause of BAV. Subsequent studies on BAV patients using linkage analysis have demonstrated high heritability.

Early identification of those patients with BAV disease who are at risk for ascending aneurysm formation and its complications may allow early intervention to prevent rupture, dissection and emergent cardiac surgery in at risk patients. Conversely, identification of those patients with BAVs not at risk for aortic aneurysm formation would delineate which patients do not need close follow up of aortic size or prophylactic ascending aortic replacement at time of aortic valve replacement.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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45 specimens collected from BAV patients

No interventions assigned to this group

45 specimens collected from TAV patients

No interventions assigned to this group

15 specimens collected from CABG pts

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients \> or = to 18 years of age
* Presenting with aortic stenosis and to undergo elective aortic valve replacement or repair with or without aortic aneurysm dilation repair
* Able to sign informed consent document

Exclusion Criteria

* Patients unable to provide informed consent for any reason
* Patients with predominant aortic regurgitation valve disease
* Patients with other known connective tissue disorders (such as Marfan's Syndrome, Ehlers-Danlos Syndrome)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Brinkman, MD

Role: PRINCIPAL_INVESTIGATOR

The Heart Hospital Baylor Plano

Locations

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The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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010-161

Identifier Type: -

Identifier Source: org_study_id

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