Clinical Trial: Microparticles in Severe Aortic Stenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Brief Summary:

Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves.

In patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.


Detailed Summary:

Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. Inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels.

Patients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.


Sponsor: InCor Heart Institute

Current Primary Outcome: Difference in microparticle levels [ Time Frame: Day 5 ]

Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endothelial microparticle levels [ Time Frame: Day 5 ]
    Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
  • Macrophage microparticle levels [ Time Frame: Day 5 ]
    Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
  • Platelet microparticle levels [ Time Frame: Day 5 ]
    Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement


Original Secondary Outcome:

  • Endothelial micropaticle levels [ Time Frame: Day 1 ]
  • Macrophage microparticle levels [ Time Frame: Day 1 ]
  • Platelet microparticle levels [ Time Frame: Day 1 ]


Information By: InCor Heart Institute

Dates:
Date Received: July 11, 2014
Date Started: June 2014
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016