Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-01 @ 2:43 AM
Study NCT ID:
NCT02193035
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microparticles in Severe Aortic Stenosis
Sponsor:
InCor Heart Institute
Organization:
Study Overview
Official Title:
Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Patients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: