Bichat Claude Bernard Hospital
Paris, 75018, France
NCT Number: NCT02287792
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75018, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
Time frame: 7 days
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: 6 months
Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
Time frame: 6 months
1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
Time frame: 6 months
number of dead patients 6 months after inclusion
Time frame: 6 months
Clinical and biological determinants of therapeutic changes
Time frame: 6 months
questionnaire
Assistance Publique - Hôpitaux de Paris
Other
Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
Acronym: TEPvENDO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
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