Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
|ClinicalTrials.gov Identifier: NCT01916005|
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : August 5, 2013
Last Update Posted : August 24, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Prosthetic Valve Endocarditis (PVE)||Device: 18F-FDG PET/CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||March 2017|
Device: 18F-FDG PET/CT
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916005
|Contact: FRANCK THUNYemail@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: franck thuny firstname.lastname@example.org|
|Principal Investigator: franck THUNY|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|