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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02193035 |
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Date of registration:
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11/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Microparticles in Severe Aortic Stenosis
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Scientific title:
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Microparticles as an Inflammatory Marker in Severe Aortic Stenosis. |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02193035 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Julio F Marchini, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heart Institute - InCor. University of Sao Paulo Medical School |
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Name:
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Pedro Lemos, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heart Institute - InCor. University of Sao Paulo Medical School |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aortic Valve Stenosis
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Intervention(s)
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Other: Microparticle levels
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Primary Outcome(s)
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Difference in microparticle levels
[Time Frame: Day 5]
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Secondary Outcome(s)
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Platelet microparticle levels
[Time Frame: Day 5]
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Endothelial microparticle levels
[Time Frame: Day 5]
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Macrophage microparticle levels
[Time Frame: Day 5]
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Secondary ID(s)
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31446114.1.0000.0068
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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