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

February 9, 2014 updated by: Sara Shimoni, Kaplan Medical Center

Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography

There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
  2. 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

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

  • Israel
      • Rehovot, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
        • Contact:

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

Ages Eligible for Study

18 years to 92 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Aortic stenosis
  • Control with aortic stenosis

Exclusion Criteria:

  • No

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

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Aortic setnsosi
blood test
Other: Blood test
Blood test
Other: controls
blood test
Other: Blood test
Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death or need for intervantion in correlation to endothelial progenitor cells
Time Frame: 4 years
We will assess wether endothelial progenitor cells can predict outcome
4 years

Collaborators and Investigators

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

Sponsor

Kaplan Medical Center

Investigators

  • Principal Investigator: Sara Shimoni, MD, Kaplan Medical

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

July 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 9, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kap118711ctil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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