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Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity

Primary Purpose

Aortic Stenosis, Cardiac Death

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Blood test
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Aortic Stenosis focused on measuring aortic stenosis

Eligibility Criteria

18 Years - 92 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Exclusion Criteria:

  • No

Sites / Locations

  • Kaplan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Aortic setnsosi

controls

Arm Description

blood test

blood test

Outcomes

Primary Outcome Measures

Cardiac death or need for intervantion in correlation to endothelial progenitor cells
We will assess wether endothelial progenitor cells can predict outcome

Secondary Outcome Measures

Full Information

First Posted
February 3, 2014
Last Updated
February 9, 2014
Sponsor
Kaplan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02060071
Brief Title
Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity
Official Title
Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.
Detailed Description
Degenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and increases in prevalence with age. Severe aortic valve stenosis accounts for considerable disease and death, especially in older patients. Aortic valve stenosis is the primary indication for valve replacement in western countries, and the number will only increase as elderly people are a growing subpopulation. Measures to identify AV disease earlier, to identify factors that influence disease progression and treat AV disease pharmacologically or with less invasive approaches would be a significant improvement over the current standard of care. These advances will only be possible with a better understanding the mechanisms underlying valve development and disease. Preliminary data suggest a novel pathophysiological concept for impaired valvular endothelial cells regeneration, leading to the progression of age-associated calcific AV disease and a potential treatment target is the disrupted endothelial cell layer of the valve leaflet. The research objectives are: To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis. To study the association between aortic stenosis progression, severity, symptoms and left ventricular function and the number and function of circulating endothelia progenitor cells. By understanding the correlation between valve severity, left ventricular longitudinal function and endothelial progenitor cells we will indentify high risk patients population that need early intervention. We hope to add new information on the pathogenesis of aortic stenosis and to indentify factors that predict disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Cardiac Death
Keywords
aortic stenosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aortic setnsosi
Arm Type
Other
Arm Description
blood test
Arm Title
controls
Arm Type
Other
Arm Description
blood test
Intervention Type
Other
Intervention Name(s)
Blood test
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
Cardiac death or need for intervantion in correlation to endothelial progenitor cells
Description
We will assess wether endothelial progenitor cells can predict outcome
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with Aortic stenosis Control with aortic stenosis Exclusion Criteria: No
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Shimoni, MD
Phone
972-505759131
Email
sara_s@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Shimoni, MD
Organizational Affiliation
Kaplan Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzi Trepp
Phone
972-8-9440069
Email
suzitr@clalit.org.il

12. IPD Sharing Statement

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Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity

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