Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Recruitment status was: Recruiting
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis|
- the diagnosis of prosthetic valve infective endocarditis [ Time Frame: 39months ]18F-fluorodeoxyglucose positron emission tomography
- 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)
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01916005
|Contact: FRANCK THUNYfirstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: franck thuny email@example.com|
|Principal Investigator: franck THUNY|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|