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

Primary Purpose

Prosthetic Valve Endocarditis (PVE)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18F-FDG PET/CT
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prosthetic Valve Endocarditis (PVE)

Eligibility Criteria

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

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endocarditis

Arm Description

Outcomes

Primary Outcome Measures

the diagnosis of prosthetic valve infective endocarditis
18F-fluorodeoxyglucose positron emission tomography

Secondary Outcome Measures

the reproducibility of the technique,
the other diagnostic parameters of PET/CT (specificity and predictive values)
the comparison of the sensitivity of PET/CT with that of echocardiography,
the other diagnostic parameters of PET/CT (specificity and predictive values)
the rate of detection of embolic events,
the other diagnostic parameters of PET/CT (specificity and predictive values)
the prognostic value of the technique (death/valve surgery)
the other diagnostic parameters of PET/CT (specificity and predictive values)

Full Information

First Posted
May 22, 2013
Last Updated
April 21, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01916005
Brief Title
Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Official Title
Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Valve Endocarditis (PVE)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endocarditis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
18F-FDG PET/CT
Primary Outcome Measure Information:
Title
the diagnosis of prosthetic valve infective endocarditis
Description
18F-fluorodeoxyglucose positron emission tomography
Time Frame
39months
Secondary Outcome Measure Information:
Title
the reproducibility of the technique,
Description
the other diagnostic parameters of PET/CT (specificity and predictive values)
Time Frame
39 months
Title
the comparison of the sensitivity of PET/CT with that of echocardiography,
Description
the other diagnostic parameters of PET/CT (specificity and predictive values)
Time Frame
39 MONTHS
Title
the rate of detection of embolic events,
Description
the other diagnostic parameters of PET/CT (specificity and predictive values)
Time Frame
39 MONTHS
Title
the prognostic value of the technique (death/valve surgery)
Description
the other diagnostic parameters of PET/CT (specificity and predictive values)
Time Frame
39 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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