NCT02193035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

July 11, 2014

Last Update Submit

April 12, 2016

Conditions

Aortic Valve Stenosis

Keywords

MicroparticlesSevere aortic stenosisCalcified aortic stenosistranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

  • Difference in microparticle levels

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

    Day 5

Secondary Outcomes (3)

  • Endothelial microparticle levels

    Day 5

  • Macrophage microparticle levels

    Day 5

  • Platelet microparticle levels

    Day 5

Study Arms (1)

Single group

EXPERIMENTAL

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

Other: Microparticle levels

Interventions

Microparticle levelsOTHER

Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis

Single group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical indication to be treated with transcatheter aortic valve replacement.

You may not qualify if:

  • Non native aortic valve
  • Moderate aortic regurgitation
  • The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 27063005RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Pedro Lemos, MD PhD

    Heart Institute - InCor. University of Sao Paulo Medical School

    STUDY CHAIR

  • Julio F Marchini, MD PhD

    Heart Institute - InCor. University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 17, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)