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Microparticles in Severe Aortic Stenosis

Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02193035
Enrollment
15
Registered
2014-07-17
Start date
2014-06-30
Completion date
2015-06-30
Last updated
2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement

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 description

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.

Interventions

OTHERMicroparticle levels

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

Sponsors

InCor Heart Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in microparticle levelsDay 5Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Secondary

MeasureTime frameDescription
Endothelial microparticle levelsDay 5Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Macrophage microparticle levelsDay 5Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Platelet microparticle levelsDay 5Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026