- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02806310
Podocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease
Clinical Predictive Value of Podocan and Wnt Regulatory Molecules in Development of Aortopathy in Bicuspid Aortic Valve Disease
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Cooperstown, New York, United States, 13326
- Bassett Healthcare Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prospective
Group A: Patients with known BAV who are scheduled to have a cardiac MRI.
|
blood sampling for biomarker levels
|
Historic
Group B: Patients with known BAV who have already had an MRI within the past year
|
blood sampling for biomarker levels
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: daniel Katz, MD, Bassett Healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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