Microparticles in Severe Aortic Stenosis

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Other: Microparticle levels

• Registration Number: NCT02193035
• Lead Sponsor: InCor Heart Institute

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	Microparticle levels	Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.

Primary Outcome Measures

Name	Time	Method
Difference in microparticle levels	Day 5	Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Secondary Outcome Measures

Name	Time	Method
Endothelial microparticle levels	Day 5	Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Macrophage microparticle levels	Day 5	Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Platelet microparticle levels	Day 5	Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Trial Locations

Locations (1)

Heart Institute - InCor. University of Sao Paulo Medical School; 🇧🇷 São Paulo, Brazil