Infective Endocarditis, Native Valve Endocarditis
Conditions
Keywords
PET/CT, FDG, Duke Criteria
Brief summary
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.
Interventions
None listed
Sponsors
Montreal Heart Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Possible IE that will be appropriately reclassified | 3 months | Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria. |
Secondary
| Measure | Time frame |
|---|---|
| Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves | 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 |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions | 3 months | — |
| Difference in the area under the curve (c-statistic) of the Duke criteria with TEE but excluding FDG-PET, with TEE and FDG-PET, and with FDG-PET but excluding TEE | 3 months | — |
| Correlation between the diagnostic accuracy and available demographic, technical, and clinical factors | 3 months | Correlation between the diagnostic accuracy (false-negative/false-positive studies versus truenegative/true-positive) and the available demographic and clinical factors (age, sex, duration of antibiotherapy, blood glucose, CRP, history of renal failure, history of malignancy, history of diabetes, chronic liver disease, time since onset of symptoms, and quality of myocardial suppression) as well as camera system (analog vs digital) |
Countries
Canada
Outcome results
None listed