Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parametric positron emission computed tomography.
- Who it may be relevant to
- Registry conditions: Endocarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
Overview
The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.
Detailed description
In addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way.
The definitive diagnosis according to the Duke-Li criteria will be established three months later in a multidisciplinary consultation meeting.
The final diagnosis according to the Duke-Li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up.
Results and all the complementary work-up.
Interventions
- Device Parametric positron emission computed tomography
Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy
Primary outcome measures
- Determination of diagnostic value of parametric positron emission computed tomography [Time frame: 3 months]
Secondary outcome measures (1)
- Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Age superior to18 years,
- Effective contraception for women of childbearing age or negative pregnancy test on the day of the exam
- Good general condition. WHO ≤ 1
- Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago
- Labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography
- Standard positron emission computed tomography planned as part of the extension assessment
- Informed and signed consent before any specific study procedure.
- Patient affiliated to the social security system
Exclusion criteria
- Presence of an active cancer in the previous three years
- Pregnancy or breastfeeding
- Poorly controlled diabetic patients
- Protected adults (under guardians or curators)
- Impossible decubitus (orthopnea, ...),
- Hypersensitivity to FDG or to one of the excipients of the radiopharmaceutical.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT05146180 · CHB18.10