Microparticles in Severe Aortic Stenosis

University of São Paulo (USP)

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Other: Microparticle levels

Study type: Interventional

Funder types: Other

Identifiers

NCT02193035

31446114.1.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Single group

Experimental group

Description:

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

Treatment:

Other: Microparticle levels