Recruiting

FDG-PET/CT

Sponsor:

Montreal Heart Institute

Code:

NCT04792281

Conditions

Infective Endocarditis

Native Valve Endocarditis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Infective Endocarditis

Native Valve Endocarditis

Study ID

NCT04792281

Start date

Aug 31, 2021

Status verified date

Nov, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

97 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with suspected native valve endocarditis

Primary outcome measure

  • Proportion of patients with Possible IE that will be appropriately reclassified [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Montreal Heart Institute

Recruiting

Montréal, Quebec, Canada, H3l 3c1

Contacts

More Information

Sponsor

Montreal Heart Institute

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • PET/CT
  • FDG
  • Duke Criteria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2024-11-22.