Prosthetic Valve Endocarditis (PVE) Clinical Trial
Official title:
Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
| Verified date | April 2023 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 174 |
| Est. completion date | April 21, 2023 |
| Est. primary completion date | March 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the diagnosis of prosthetic valve infective endocarditis | 18F-fluorodeoxyglucose positron emission tomography | 39months | |
| Secondary | the reproducibility of the technique, | the other diagnostic parameters of PET/CT (specificity and predictive values) | 39 months | |
| Secondary | the comparison of the sensitivity of PET/CT with that of echocardiography, | the other diagnostic parameters of PET/CT (specificity and predictive values) | 39 MONTHS | |
| Secondary | the rate of detection of embolic events, | the other diagnostic parameters of PET/CT (specificity and predictive values) | 39 MONTHS | |
| Secondary | the prognostic value of the technique (death/valve surgery) | the other diagnostic parameters of PET/CT (specificity and predictive values) | 39 MONTHS |