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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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).

Condition or disease Intervention/treatment Phase
Endocarditis Diagnostic Test: Whole-body 18F-FDG PET-CT scan Not Applicable

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.


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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.
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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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:

  • 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.

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): NCT03695861


Contacts
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Contact: Cécile ALEXANDRINO, MD 05 57 65 64 31 ext +33 cecile.alexandrino@chu-bordeaux.fr
Contact: Philippe PRUNIER 05 57 65 66 55 ext +33 philippe.prunier@chu-bordeaux.fr

Locations
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France
University hospital, Bordeaux Active, not recruiting
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Cécile ALEXANDRINO, MD University Hospital, Bordeaux
Study Chair: Paul PEREZ, MD,PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03695861     History of Changes
Other Study ID Numbers: CHUBX 2017/33
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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

Keywords provided by University Hospital, Bordeaux:
Endocarditis Infectious
Native valve
ESC 2015 modified diagnostic criteria
18F-FDG PET-CT
Detection of peripheral emboli

Additional relevant MeSH terms:
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Streptococcal Infections
Communicable Diseases
Infection
Endocarditis
Embolism
Endocarditis, Subacute Bacterial
Heart Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Endocarditis, Bacterial
Bacterial Infections
Gram-Positive Bacterial Infections
Cardiovascular Infections
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action