Actively Recruiting
Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Led by Montreal Heart Institute · Updated on 2024-11-22
97
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter prospective observational study to understand the impact of FDG-PET/CT imaging on patients suspected of having native valve infective endocarditis (NVE). The study focuses on patients classified as having Possible Infective Endocarditis (IE) using the modified Duke criteria and are evaluated at one of six participating hospitals, including specialized cardiac and tertiary care centers. This study aims to improve the diagnosis and management of native valve infections. Participants undergo FDG-PET/CT scans as part of their evaluation. The study does not involve any investigational drugs or treatments but observes how the addition of FDG-PET/CT affects diagnostic classification and management decisions. It also examines various diagnostic performance measures such as sensitivity and specificity of FDG-PET and the Duke criteria with or without transesophageal echocardiography (TEE). Throughout the study, researchers will monitor participants for up to three months to assess outcomes including reclassification of diagnosis, detection of septic emboli, and incidental findings like cancer. Data collection includes imaging results, clinical assessments, and comparisons of imaging uptake values. Safety considerations include the ability of patients to tolerate the PET/CT scan and exclusion of those with prosthetic valves, pregnancy, or high body mass index. The total study participation time aligns with clinical follow-up over several months.
CONDITIONS
Brief Title
Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older and able to provide informed consent
- Referred for an FDG-PET/CT study
- Classified as having Possible Infective Endocarditis before FDG-PET/CT imaging
- Able to tolerate the physical and logistical requirements of a PET/CT scan
You will not qualify if you...
- Presence of prosthetic cardiac valve or cardiac implantable electronic device (CIED)
- Pregnant or breastfeeding women
- Body mass index greater than 45 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo FDG-PET/CT imaging to evaluate native valve infective endocarditis.
1 visit (in-person)
Duration - 3 months
Participants are monitored for outcomes related to infective endocarditis classification and imaging results.
Follow-up assessments may occur depending on clinical need
Trial Site Locations
Total: 6 locations
1
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Not Yet Recruiting
2
Montreal Heart Institute
Montreal, Quebec, Canada, H3l 3c1
Actively Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
4
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
5
University Institute of Cardiology and Respirology of Quebec
Québec, Quebec, Canada, G1V 4G5
Not Yet Recruiting
6
Centre Hospitalier de l'Universite de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5H3
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here