CompletedNot Applicable

Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

France31 participantsStarted 2018-11-10

Plain-language summary

The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of \[18F\]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient ≥ 18 years treated at the university hospital center of Bordeaux for suspicion of infectious endocarditis on a native valve with a "definite" or "possible" diagnosis according to the ESC 2015 modified diagnostic criteria, agreeing to participate, * Affiliated person or beneficiary of a social security scheme, * Free, informed and written consent (no later than the day of inclusion and before any exam required by the research). Exclusion Criteria: * Patient with a vital failure (haemodynamic, respiratory or neurological instability), requiring treatment in the intensive care unit and / or urgent surgery incompatible with performing PET-CT, * Pregnant or nursing woman, * Patient who has already been treated for infective endocarditis within six months of enrollment, * Patient who had cardiac surgery in the two months preceding inclusion, * Patient who has previously been hypersensitive to fluorodeoxyglucose and / or excipients of the radiotracer, * Patient unable to sign consent, * Patient under legal protection, * Women of childbearing age who do not benefit from effective contraception (HAS criteria), * Patient in a period of relative exclusion from another research protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of the 18F-FDG PET-CT in the diagnosis of infectious endocarditis

Timeframe: 3 month

Trial details

NCT IDNCT03695861

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-16

View on ClinicalTrials.gov More Endocarditis trials