Podocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease

February 28, 2022 updated by: Daniel Katz, Bassett Healthcare

Clinical Predictive Value of Podocan and Wnt Regulatory Molecules in Development of Aortopathy in Bicuspid Aortic Valve Disease

Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to play role in abnormal aortic distensibility and stiffness with impairment of aortic elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not understood completely. In a recent study podocan is found in extracellular matrix (ECM) of human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no current effective therapy that can alter the progression of aortic dilatation in bicuspid valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta and aortic dissection. In this study the aim is to investigate the association between podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide more effective and physiological understanding of disease process and potential target in prevention and treatment for aortopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with known BAV will be enrolled in two inclusion criteria categories:

- Group A: Patients who are scheduled to have a cardiac MRI

Procedures for Group A: MRI will be used as a standard procedure to confirm the morphology of bicuspid valve especially in uncertain cases and to do accurate aortic measurements. Patients who agree to participate will provide informed consent prior to their cardiac MRI/CT. A 6 minute walk test to measure baseline functional status will be performed after consent. All patients having a cardiac MRI/CT have an IV line placed as normal procedure. When then line has been placed, prior to contrast infusion a blood sample will be collected to test for circulatory Podocan and Wnt pathway molecules. At 24 months post procedure the following information will be collected from the participants' charts for endpoint analysis:

  • All cause mortality
  • Hospital admissions for Aortic dissection, Congestive heart failure, endocarditis or cardiac death

  • Valve replacement or aortic graft surgery

    • Group B: Patients who have already had an MRI within the past year

Procedures for Group B: MRI will be used as a standard procedure to confirm the morphology of bicuspid valve especially in uncertain cases and to do accurate aortic measurements. Patients who agree to participate will report to the Clinical Research Division (CRD ) for a research visit to enroll in the study. At this visit, the patient will provide informed consent, complete a 6 minute walk test to measure baseline functional status , and will have blood drawn by venipuncture to obtain a blood sample to test for circulatory Podocan and Wnt pathway molecules. At 24 months post procedure the following information will be collected from the participants' charts for endpoint analysis:

  • All cause mortality
  • Hospital admissions for Aortic dissection, Congestive heart failure, endocarditis or cardiac death
  • Valve replacement or aortic graft surgery

All patients who do undergo valve replacement or aortic graft surgery within the 24 month follow up period, will have their valve tissue samples analyzed for podocan levels. These tissues are removed as a routine part of the surgery and sent to the clinical laboratory at Bassett. The number of tissue samples collected during this procedure can range from one to four based on the exact nature and location of the aortic pathology. The Bassett Clinical Lab will prepare additional paraffin blocks and slides of the tissue for the research study.

A blood sample will also be taken at the time of the patient's post-op MRI to test for circulatory Podocan and Wnt pathway molecules. This usually occurs about 6-9 months after surgery.

It is expected that 100 participants will be enrolled in the study over 18 months. This is a sample size of convenience for this pilot study based the current volume of patients undergoing cardiac MRI/CT for evaluation of valvular disease. Of these 100 patients, it is estimated that 25 will undergo surgery as described above within the study period.

Baseline analysis will be performed to study the association between circulatory Podocan and Wnt regulatory molecules (Wnt-1, Wnt-3, Dkk-1, WIF-1, sFRP-1, sFRP-3) measured by ELISA in peripheral blood and tissue samples of aortic root/ascending aorta.

Each participant's chart will be reviewed at the time of enrollment and the following variables will be abstracted from the medical record:

  • age,
  • gender,
  • ethnicity,
  • Most recent Ht, Wt, BP, HR
  • BMI
  • Tobacco use/history
  • Alcohol use/ history

  • Comorbidities

    • HTN
    • Hyperlipidemia
    • Diabetes
    • CKD
    • Cancer
    • CAD

  • Info from previous echocardiogram:

    • Ejection fraction
    • Valve area
    • Gradient

  • Info from previous cardiac cath (if done):

    • Presence/absence of coronary stenosis
    • Location and degree of stenosis
    • Aortic valve area
    • Calculation of valve area

  • Info from previous ECG:

    • Rhythm
    • LVH
  • Medications

  • Laboratory data:

    • Lipids
    • Chemistries
    • CBC
    • HgA1C
    • Troponin
    • BNP

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with known BAV.

Description

Inclusion Criteria:

  • Age 18 or greater
  • Patients with known BAV diagnosed by echocardiography, previous MRI, or cardiac CT
  • Scheduled for cardiac MRI or have had a cardiac MRI within the past year
  • Able to provide informed consent
  • Ambulatory and expected to be able to complete 6 minute walk test

Exclusion Criteria:

  • Patients without BAV
  • Patients who have already had surgery for aortic valve problems and/or aortopathy
  • Unable to complete 6 minute walk test (ex. Wheelchair bound)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prospective
Group A: Patients with known BAV who are scheduled to have a cardiac MRI.
Other: Blood draw
blood sampling for biomarker levels
Historic
Group B: Patients with known BAV who have already had an MRI within the past year
Other: Blood draw
blood sampling for biomarker levels

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Circulatory podocon levels
Time Frame: Day 1
Day 1
circulatory WNT pathway molecule levels
Time Frame: Day1
Day1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
podocon expression in aortic tissue
Time Frame: 24 months
24 months
WNT pathway molecule expression in aortic tissue
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bassett Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: daniel Katz, MD, Bassett Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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