Impact of FDG-PET/CT on Management of Patients With Native Valve Infective Endocarditis

Study Overview
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Brief Summary
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The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.

Official Title
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Impact of FDG-PET/CT on Management of Patients With Native Valve Infective Endocarditis

Conditions
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Infective Endocarditis, Native Valve Endocarditis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older, capable to provide informed consent; Referred for a FDG-PET/CT study Classified as having Possible IE prior to FDG-PET/CT imaging; Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan. Exclusion Criteria: Subjects with prosthetic cardiac valve and/or CIED; Pregnant or breastfeeding female; Body mass index > 45 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected native valve endocarditis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Possible IE that will be appropriately reclassified | Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE |  | 3 months | 
| Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVESensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVE |  | 3 months | 
| Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE |  | 3 months | 
| Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves |  | 3 months | 
| Differences target-to-background ratio (TBR) between infected and non-infected valves |  | 3 months | 
| Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET |  | 3 months | 
| Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET |  | 3 months | 
| Differences in the rate of sub-optimal suppression protocol between males and females |  | 3 months | 
| Proportion of patients with incidental cancer identified on FDG-PET |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, FDG, Duke Criteria