NCT01194362

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 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

June 20, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

12.3 years

First QC Date

September 1, 2010

Last Update Submit

January 23, 2026

Conditions

Aortic Valve Disease

Keywords

aortic valve diseasegene expression

Outcome Measures

Primary Outcomes (1)

  • Determine differences in genetic expression profiles using mRNA transcriptional analysis

    Determine differences in genetic expression profiles using mRNA transcriptional analysis in the three groups: subjects with bicuspid aortic valves with aortic stenosis, subjects with tricuspid aortic valves with stenosis, and subjects without aortic valve disease.

    12 month

Secondary Outcomes (2)

  • Determine differences in the association between genetic expression profiles and aortic dilation in the two aortic valve disease groups.

    12 months

  • Determine the association between expression of inflammatory markers/impaired response to oxidative stress and stenotic aortic valve disease.

    12 months

Study Arms (3)

45 specimens collected from BAV patients

45 specimens collected from TAV patients

15 specimens collected from CABG pts

Eligibility Criteria

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

Hospital facility

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Tissue

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • William Brinkman, MD

    The Heart Hospital Baylor Plano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 3, 2010

Study Start

June 20, 2010

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(1)