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

NCT01916005 | Completed

• 2 other identifiers: 2013-A00056-392013-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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).

Conditions

Prosthetic Valve Endocarditis (PVE)

Outcome Measures

Primary Outcomes (1)

• the diagnosis of prosthetic valve infective endocarditis

  18F-fluorodeoxyglucose positron emission tomography

  39months

Secondary Outcomes (4)

• the reproducibility of the technique,

  39 months

• the comparison of the sensitivity of PET/CT with that of echocardiography,

  39 MONTHS

• the rate of detection of embolic events,

  39 MONTHS

• the prognostic value of the technique (death/valve surgery)

  39 MONTHS

Study Arms (1)

endocarditis

EXPERIMENTAL

Device: 18F-FDG PET/CT

Interventions

18F-FDG PET/CT DEVICE

endocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: August 5, 2013
• Study Start: February 5, 2014
• Primary Completion: March 20, 2018
• Study Completion: April 21, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (1)