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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)

Primary Purpose

Endocarditis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Whole-body 18F-FDG PET-CT scan
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endocarditis focused on measuring Endocarditis Infectious, Native valve, ESC 2015 modified diagnostic criteria, 18F-FDG PET-CT, Detection of peripheral emboli

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University hospital, Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole-body 18F-FDG PET-CT scan

Arm Description

Outcomes

Primary Outcome Measures

Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2018
Last Updated
October 5, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03695861
Brief Title
Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves
Acronym
NATIVTEP
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis
Keywords
Endocarditis Infectious, Native valve, ESC 2015 modified diagnostic criteria, 18F-FDG PET-CT, Detection of peripheral emboli

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole-body 18F-FDG PET-CT scan
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole-body 18F-FDG PET-CT scan
Intervention Description
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 Measure Information:
Title
Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis
Description
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.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile ALEXANDRINO, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul PEREZ, MD,PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University hospital, Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

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