Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves (NATIVTEP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33604
- University Hospital, Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole-body 18F-FDG PET-CT scan
|
A 18F-FDG PET-CT will be performed within 5 days of the beginning of the patients care with infectious endocarditis at the University Hospital center of Bordeaux.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
Time Frame: 3 month
|
The reference test in this study will be a "definite diagnosis" of infectious endocarditis according to the ESC 2015 modified criteria at three months of follow-up, evaluated by a multidisciplinary committee in infectious endocarditis.
This evaluation will be done blind to the results of the PET-CT of the study.
The index test 18F-FDG PET-CT will have been performed at the initial phase of patient management.
|
3 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cécile ALEXANDRINO, MD, University Hospital, Bordeaux
- Study Chair: Paul PEREZ, MD,PhD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Heart Diseases
- Infections
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Cardiovascular Infections
- Endocarditis, Bacterial
- Endocarditis
- Endocarditis, Subacute Bacterial
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- CHUBX 2017/33
- 2018-A00134-51 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.