Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Proportion of patients with a change in IE therapeutic plan
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged ≥ 18 years
- •Presenting IE "Duke-Li definite - Duke-Li possible" or strong suspicion of IE "Duke-Li not definite or possible, with initiation of IE antibiotic therapy".
- •Transthoracic or transesophageal ultrasound performed.
- •A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization
- •Absence of cardiac surgery for the current IE episode
- •Covered by the French health insurance system
- •Having given and signed the written study informed consent to the study.
Exclusion Criteria
- •Patient having already had a 18-FDG PET/CT in the current episode
- •Contraindication to perform a 18-FDG PET/CT
- •Early prosthetic valve IE (cardiac surgery within last 2 months)
- •Inability to understand the information form
- •Pregnant or lactating woman.
- •Cardiac surgery between inclusion and 18-FDG PET/CT
- •Participation to any clinical trial including 18-FDG PET/CT
Arms & Interventions
18-FDG PET/CT scan
All patients will undergo a whole body PET/CT scan
Intervention: 18-FDG PET/CT scan (Procedure)
Outcomes
Primary Outcomes
Proportion of patients with a change in IE therapeutic plan
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...)
Secondary Outcomes
- Proportion of patients with Duke-Li classification modifications(6 months)
- Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures(6 months)
- 18-FDG PET/CT inter-reader reproducibility(6 months)
- 6-month mortality rate(6 months)
- Determinants of change in therapeutic plan as defined in primary outcome(6 months)