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

Recruiting

• Conditions: Infective Endocarditis; Native Valve Endocarditis

• Registration Number: NCT04792281
• Lead Sponsor: Montreal Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-10
• Study Start: 2021-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE	3 months
Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET	3 months
Differences target-to-background ratio (TBR) between infected and non-infected valves	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
Differences in maximal standardized uptake value (SUVmax) 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
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

Trial Locations

Locations (6)

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montréal, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada

Centre Hospitalier de l'Universite de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

University Institute of Cardiology and Respirology of Quebec; 🇨🇦 Quebec, Canada