Clinical trial NCT03695861: Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
Official title: Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocarditis
Keywords: Endocarditis Infectious
Native valve
ESC 2015 modified diagnostic criteria
18F-FDG PET-CT
Detection of peripheral emboli
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic study, prospective, "delayed-type cross-sectional study" (the result of the reference test is defined at 3 months of follow-up), monocentric, blinded, including consecutive patients.
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of \[18F\]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).

Detailed description: Infectious endocarditis remains a serious pathology with an intra-hospital mortality of between 15 and 30%. The prognosis of patients depends on the speed of diagnosis and the beginning of the appropriate treatment.

Currently, the diagnosis of endocarditis is based on the ESC 2015 modified criteria. Echocardiography techniques play a key role, but can be negative in 20% of endocarditis. 18F-FDG PET-CT showed promising results in the management of prosthetic valve endocarditis and / or stimulation material.

However, few studies have been carried out on the contribution of PET-CT in the diagnosis of endocarditis on native valves, with discordant results. But this is the majority of endocarditis (70% of cases).

A 18F-FDG PET-CT will be performed in all patients included in the study in addition to standard care for endocarditis, within 5 days of the beginning of their management in the university hospital center of Bordeaux after verification of inclusion and exclusion criteria and signature of consent.

The included patients will be reviewed at Month 3 during a consultation with the completion of a clinical examination, an electrocardiogram, a biological assessment and a transthoracic ultrasound.

Adverse events and serious adverse events will be collected throughout the study.

Eligibility criteria: Inclusion Criteria:

* Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate,
* Affiliated person or beneficiary of a social security scheme,
* Free, informed and written consent (no later than the day of inclusion and before any exam required by the research).

Exclusion Criteria:

* Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT,
* Pregnant or nursing woman,
* Patient who has already been treated for infective endocarditis within six months of enrollment,
* Patient who had cardiac surgery in the two months preceding inclusion,
* Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer,
* Patient unable to sign consent,
* Patient under legal protection,
* Women of childbearing age who do not benefit from effective contraception (HAS criteria),
* Patient in a period of relative exclusion from another research protocol.

Primary outcomes:
measure: Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: University hospital, Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Cécile ALEXANDRINO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Paul PEREZ, MD,PhD
role: STUDY_CHAIR
References: