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

Montreal Heart Institute97 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infective Endocarditis Native Valve Endocarditis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE

Time frame: 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

Time frame: 3 months

Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE

Time frame: 3 months

Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves

Time frame: 3 months

Differences target-to-background ratio (TBR) between infected and non-infected valves

Time frame: 3 months

Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET

Time frame: 3 months

Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET

Time frame: 3 months

Differences in the rate of sub-optimal suppression protocol between males and females

Time frame: 3 months

Data from ClinicalTrials.gov

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