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NCT Number: NCT04792281

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

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.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases Native Valve Endocarditis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients with Possible IE that will be appropriately reclassified

    Time frame: 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 outcomes

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

    Time frame: 3 months

  2. 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

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

  9. Proportion of patients with incidental cancer identified on FDG-PET

    Time frame: 3 months

Other outcomes

  1. Correlation between the diagnostic accuracy and available demographic, technical, and clinical factors

    Time frame: 3 months

    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)

  2. 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

  3. Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Acronym: PET-NAVIE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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