Aortic Valve StenosisNCT02193035
Microparticles in Severe Aortic Stenosis
A study testing Microparticle levels in people with Aortic Valve Stenosis, run by InCor Heart Institute at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Microparticle levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication to be treated with transcatheter aortic valve replacement.
Who cannot join
- Non native aortic valve
- Moderate aortic regurgitation
- The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Microparticle levels
- Keywords
- Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microparticle levelsOther
Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR. Receives: Other: Microparticle levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in microparticle levels
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Measured: Day 5
Secondary outcomes (3)
Endothelial microparticle levels
Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Measured: Day 5
Macrophage microparticle levels
Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Measured: Day 5
Platelet microparticle levels
Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro A. Lemos, InCor Heart Institute
- Investigators
- Pedro Lemos, MD PhD, Study chair, Heart Institute - InCor. University of Sao Paulo Medical SchoolJulio F Marchini, MD PhD, Principal investigator, Heart Institute - InCor. University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193035
- Sponsor's protocol ID
- 31446114.1.0000.0068
- Status last verified
- Apr 2016
- First submitted
- 11 Jul 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27063005
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
- ClinicalTrials.gov ID
- NCT02193035
- Acronym / sponsor ID
- 31446114.1.0000.0068
- Conditions
- Aortic Valve Stenosis
- Keywords
- Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Other: Microparticle levelsPatients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical indication to be treated with transcatheter aortic valve replacement.
Key exclusion criteria (3 listed)
- Non native aortic valve
- Moderate aortic regurgitation
- The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microparticle levelsMicroparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis | Other | Single group |
Primary outcome
Difference in microparticle levels
Time frame: Day 5
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
3 secondary outcomes
Endothelial microparticle levels
Time frame: Day 5
Macrophage microparticle levels
Time frame: Day 5
Platelet microparticle levels
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Results publication: PubMed 27063005Marchini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Lemos, MD PhD study chair
Heart Institute - InCor. University of Sao Paulo Medical School
Julio F Marchini, MD PhD principal investigator
Heart Institute - InCor. University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microparticle levels in people with Aortic Valve Stenosis, run by InCor Heart Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in microparticle levels (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.