The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Introduction: Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management. 18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated. Hypothesis: 18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization. Primary objective: To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans. Secondary objectives: * To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis * To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE * To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry * To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate * To identify clinical and biological determinants of extracardiac IE localizations and prognosis * To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
Bichat Claude Bernard Hospital
Paris, France
Proportion of patients with a change in IE therapeutic plan
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
Time frame: 7 days
Proportion of patients with Duke-Li classification modifications
Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
Time frame: 6 months
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
Time frame: 6 months
6-month mortality rate
number of dead patients 6 months after inclusion
Time frame: 6 months
Determinants of change in therapeutic plan as defined in primary outcome
Clinical and biological determinants of therapeutic changes
Time frame: 6 months
18-FDG PET/CT inter-reader reproducibility
questionnaire
Time frame: 6 months
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