Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
NCT ID: NCT03015818
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2017-01-30
2019-05-03
Brief Summary
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This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
Interventions
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18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
Eligibility Criteria
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Inclusion Criteria
* written informed consent
* SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient \> 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.
Exclusion Criteria
* Pregnancy
* Concurrent antibiotherapy
* Certain infectious endocarditis
* Concurrent anti-inflammatory therapy, including corticosteroid therapy
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, , France
Countries
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Other Identifiers
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RC16_0137
Identifier Type: -
Identifier Source: org_study_id
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