An observational study in Infective Endocarditis and Native Valve Endocarditis, sponsored by Montreal Heart Institute. Recruiting at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Montreal Heart Institute · Observational
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 97 is below the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Proportion of patients with incidental cancer identified on FDG-PET
Time frame: 3 months
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 months
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 months
Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions
Time frame: 3 months
Plan to share: Undecided
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