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Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD) (TEP-SVD)

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ClinicalTrials.gov Identifier: NCT03015818
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

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.


Condition or disease Intervention/treatment Phase
Aortic Bioprosthesis Structural Valve Dysfunction Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT




Primary Outcome Measures :
  1. 18F-Fluoride activity [ Time Frame: The day of the inclusion ]
    18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.


Secondary Outcome Measures :
  1. TBR in 18F-FDG [ Time Frame: 6 months ]
    TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process

  2. Both 18F-Fluoride and 18F-FDG TBR correlation [ Time Frame: 6 months ]
    Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18
  • 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:

  • Inability to give informed consent
  • Pregnancy
  • Concurrent antibiotherapy
  • Certain infectious endocarditis
  • Concurrent anti-inflammatory therapy, including corticosteroid therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015818


Contacts
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Contact: Nicolas PIRIOU, MCU-PH +33 2 53 48 27 81 nicolas.piriou@chu-nantes.fr

Locations
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France
Nantes University Hospital Recruiting
Nantes, France
Contact: Nicolas Piriou, MCU-PH         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03015818     History of Changes
Other Study ID Numbers: RC16_0137
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Calcium
Calcium, Dietary
Fluorides
Fluorodeoxyglucose F18
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Cariostatic Agents
Protective Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action