Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

April 21, 2023 updated by: Assistance Publique Hopitaux De Marseille

The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • unexplained persistent or recurrent fever >38°C;
  • and/or unexplained increased serum C-reactive protein (CRP) level >10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
  • and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
  • and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.

Exclusion Criteria:

  • pregnancy,
  • an inability to lie flat,
  • a need for urgent cardiac surgery,
  • hemodynamic instability,
  • cardiac surgery <1 month ago,
  • and a blood glucose level >1.8 g/L. Patients with a poor PET/CT image quality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: endocarditis
Device: 18F-FDG PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the diagnosis of prosthetic valve infective endocarditis
Time Frame: 39months
18F-fluorodeoxyglucose positron emission tomography
39months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the reproducibility of the technique,
Time Frame: 39 months
the other diagnostic parameters of PET/CT (specificity and predictive values)
39 months
the comparison of the sensitivity of PET/CT with that of echocardiography,
Time Frame: 39 MONTHS
the other diagnostic parameters of PET/CT (specificity and predictive values)
39 MONTHS
the rate of detection of embolic events,
Time Frame: 39 MONTHS
the other diagnostic parameters of PET/CT (specificity and predictive values)
39 MONTHS
the prognostic value of the technique (death/valve surgery)
Time Frame: 39 MONTHS
the other diagnostic parameters of PET/CT (specificity and predictive values)
39 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2014

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00056-39
  • 2013-01 (Other Identifier: AP HM)

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.

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