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

Infective Endocarditis Clinical Trial

— PET-NAVIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792281
• Other study ID #: MP-33-2020-2674
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• Native Valve Endocarditis

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Center	Montreal	Quebec
Canada	Centre Hospitalier de l'Universite de Montreal	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	University Institute of Cardiology and Respirology of Quebec	Quebec
Canada	Centre Hospitalier de l'Universite de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between the diagnostic accuracy and available demographic, technical, and clinical factors	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)	3 months
Other	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
Other	Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions		3 months
Primary	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	Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE		3 months
Secondary	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
Secondary	Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE		3 months
Secondary	Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves		3 months
Secondary	Differences target-to-background ratio (TBR) between infected and non-infected valves		3 months
Secondary	Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET		3 months
Secondary	Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET		3 months
Secondary	Differences in the rate of sub-optimal suppression protocol between males and females		3 months
Secondary	Proportion of patients with incidental cancer identified on FDG-PET		3 months