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OpenTrials
Completed

NCT Number: NCT02193035

Microparticles in Severe Aortic Stenosis

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical indication to be treated with transcatheter aortic valve replacement.

Exclusion criteria

  • Non native aortic valve
  • Moderate aortic regurgitation
  • The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.

Treatment and study plan

Microparticle levels

Other

Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis

Primary outcomes

  1. Difference in microparticle levels

    Time frame: Day 5

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

Secondary outcomes

  1. Endothelial microparticle levels

    Time frame: Day 5

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

  2. Macrophage microparticle levels

    Time frame: Day 5

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

  3. Platelet microparticle levels

    Time frame: Day 5

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

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study title

Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2014
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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