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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Prosthetic Valve Endocarditis (PVE)

Treatments

Device: 18F-FDG PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT01916005
2013-A00056-39
2013-01

Details and patient eligibility

About

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).

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

174 participants in 1 patient group

endocarditis
Experimental group
Treatment:
Device: 18F-FDG PET/CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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