Microparticles in Severe Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:

Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193035
• Other study ID #: 31446114.1.0000.0068
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: April 12, 2016
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Brazil	Heart Institute - InCor. University of Sao Paulo Medical School	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Marchini JF, Miyakawa AA, Tarasoutchi F, Krieger JE, Lemos P, Croce K. Endothelial, platelet, and macrophage microparticle levels do not change acutely following transcatheter aortic valve replacement. J Negat Results Biomed. 2016 Apr 11;15(1):7. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in microparticle levels	Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement	Day 5	No
Secondary	Endothelial microparticle levels	Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement	Day 5	No
Secondary	Macrophage microparticle levels	Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement	Day 5	No
Secondary	Platelet microparticle levels	Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement	Day 5	No