Completed

NCT Number: NCT01916005

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

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).

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Key information

Conditions

Prosthetic Valve Endocarditis (PVE)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FDG PET/CT

Device

Primary outcomes

the diagnosis of prosthetic valve infective endocarditis

Time frame: 39months

18F-fluorodeoxyglucose positron emission tomography

Secondary outcomes

the reproducibility of the technique,

Time frame: 39 months

the other diagnostic parameters of PET/CT (specificity and predictive values)
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)
the rate of detection of embolic events,

Time frame: 39 MONTHS

the other diagnostic parameters of PET/CT (specificity and predictive values)
the prognostic value of the technique (death/valve surgery)

Time frame: 39 MONTHS

the other diagnostic parameters of PET/CT (specificity and predictive values)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2023
First posted: Aug 5, 2013
Registry last updated: Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.