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Microparticles in Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02193035
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Pedro A. Lemos, 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.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Other: Microparticle levels Not Applicable

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  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single group
Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.
Other: Microparticle levels
Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis




Primary Outcome Measures :
  1. Difference in microparticle levels [ Time Frame: Day 5 ]
    Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement


Secondary Outcome Measures :
  1. Endothelial microparticle levels [ Time Frame: Day 5 ]
    Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

  2. Macrophage microparticle levels [ Time Frame: Day 5 ]
    Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

  3. Platelet microparticle levels [ Time Frame: Day 5 ]
    Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193035


Locations
Brazil
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
InCor Heart Institute
Investigators
Study Chair: Pedro Lemos, MD PhD Heart Institute - InCor. University of Sao Paulo Medical School
Principal Investigator: Julio F Marchini, MD PhD Heart Institute - InCor. University of Sao Paulo Medical School

Publications of Results:
Responsible Party: Pedro A. Lemos, Professor of Medicine, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT02193035     History of Changes
Other Study ID Numbers: 31446114.1.0000.0068
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pedro A. Lemos, InCor Heart Institute:
Microparticles
Severe aortic stenosis
Calcified aortic stenosis
transcatheter aortic valve replacement

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction