Brief Title
Microparticles in Severe Aortic Stenosis
Official Title
Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
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 Type
Interventional
Primary Outcome
Difference in microparticle levels
Secondary Outcome
Endothelial microparticle levels
Condition
Aortic Valve Stenosis
Intervention
Microparticle levels
Study Arms / Comparison Groups
Single group
Description: Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
15
Start Date
June 2014
Completion Date
June 2015
Primary Completion Date
June 2015
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pedro Lemos, MD PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02193035
Organization ID
31446114.1.0000.0068
Responsible Party
Principal Investigator
Study Sponsor
InCor Heart Institute
Study Sponsor
Pedro Lemos, MD PhD, Study Chair, Heart Institute - InCor. University of Sao Paulo Medical School
Verification Date
April 2016