Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves (NATIVTEP)
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|ClinicalTrials.gov Identifier: NCT03695861|
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endocarditis||Diagnostic Test: Whole-body 18F-FDG PET-CT scan||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Masking Description:||The interpretation of the PET-CT will be performed by a nuclear medicine expert who is expert in cardiac imaging and infectious pathology, blinded to other imaging tests.|
|Official Title:||Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
|Experimental: Whole-body 18F-FDG PET-CT scan||
Diagnostic Test: 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695861
|Contact: Cécile ALEXANDRINO, MD||05 57 65 64 31 ext +email@example.com|
|Contact: Philippe PRUNIER||05 57 65 66 55 ext +firstname.lastname@example.org|
|University hospital, Bordeaux||Active, not recruiting|
|Pessac, France, 33604|
|Principal Investigator:||Cécile ALEXANDRINO, MD||University Hospital, Bordeaux|
|Study Chair:||Paul PEREZ, MD,PhD||University Hospital, Bordeaux|