Clinical trial NCT04792281: Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Official title: Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infective Endocarditis
Native Valve Endocarditis
Keywords: PET/CT
FDG
Duke Criteria
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with Possible IE that will be appropriately reclassified
timeFrame: 3 months
Secondary outcomes:
measure: Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE
timeFrame: 3 months
measure: Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves
timeFrame: 3 months
measure: Differences target-to-background ratio (TBR) between infected and non-infected valves
timeFrame: 3 months
measure: Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET
timeFrame: 3 months
measure: Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET
timeFrame: 3 months
measure: Differences in the rate of sub-optimal suppression protocol between males and females
timeFrame: 3 months
measure: Proportion of patients with incidental cancer identified on FDG-PET
timeFrame: 3 months
Other outcomes:
measure: Correlation between the diagnostic accuracy and available demographic, technical, and clinical factors
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions
timeFrame: 3 months
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier de l'Universite de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: University Institute of Cardiology and Respirology of Quebec
Study officials:
References: