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Microparticles in Severe Aortic Stenosis

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Microparticle levels
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Heart Institute - InCor. University of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

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

Outcomes

Primary Outcome Measures

Difference in microparticle levels
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Secondary Outcome Measures

Endothelial microparticle levels
Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Macrophage microparticle levels
Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Platelet microparticle levels
Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement

Full Information

First Posted
July 11, 2014
Last Updated
April 12, 2016
Sponsor
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02193035
Brief Title
Microparticles in Severe Aortic Stenosis
Official Title
Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Arm Description
Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.
Intervention Type
Other
Intervention Name(s)
Microparticle levels
Intervention Description
Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis
Primary Outcome Measure Information:
Title
Difference in microparticle levels
Description
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Endothelial microparticle levels
Description
Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Time Frame
Day 5
Title
Macrophage microparticle levels
Description
Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Time Frame
Day 5
Title
Platelet microparticle levels
Description
Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Time Frame
Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Lemos, MD PhD
Organizational Affiliation
Heart Institute - InCor. University of Sao Paulo Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julio F Marchini, MD PhD
Organizational Affiliation
Heart Institute - InCor. University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute - InCor. University of Sao Paulo Medical School
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27063005
Citation
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;15:7. doi: 10.1186/s12952-016-0051-2.
Results Reference
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Microparticles in Severe Aortic Stenosis

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