Microparticles in Severe Aortic Stenosis

April 12, 2016 updated by: Pedro A. Lemos, InCor Heart Institute

Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Heart Institute - InCor. University of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in microparticle levels
Time Frame: Day 5
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial microparticle levels
Time Frame: Day 5
Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Day 5
Macrophage microparticle levels
Time Frame: Day 5
Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Day 5
Platelet microparticle levels
Time Frame: Day 5
Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31446114.1.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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