Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMontreal Heart Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Subjects with prosthetic cardiac valve and/or CIED;
Pregnant or breastfeeding female;
Body mass index > 45 kg/m2.
Trial population
The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
97 Participants
are grouped into 1 trial groupGroup A: Patients with suspected native valve endocarditis
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE
Time frame
3 months2
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 months3
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE
Time frame
3 months4
Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves
Time frame
3 monthsOther outcomes
1
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)
Time frame
3 months2
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
Time frame
3 months3
Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov