An interventional study of Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT in Infective Endocarditis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
Infectious endocarditis (IE) is a pathology where the mortality rate of between 20 and 25%, but a higher morbidity since 50% of the patients are treated by a valvular surgical procedure. The diagnosis of IE is often difficult and therefore too late. In 2015, the European Society of Cardiology recommendations published by the integrate Positron Emission Tomography with Computed Tomography (PET/CT) with 18F-Fluorodeoxyglucose (18F-FDG) in the diagnostic management of IE.
However, during conventional examinations, with 12 hours fasting and low carb dieting, myocardial uptake of 18F-FDG may be intense and interfere with results.
The purpose of this study is to assess a strict low carbohydrate diet as Atkins (\<3gram/day of carbohydrate) diet to facilitate the infective endocarditis diagnosis by 18F-FDG PET/CT Primary objective is to assess a strict low carbohydrate diet during 12h and 12h fasting for enhancing the contrast between infect area and surrounding structures and improve the detectability of infective endocarditis by PET/CT
Secondary objectives:
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 26 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled patients will be received a strict low carbohydrate (\< 3gr/day of carbohydrate) and 12h fasting before 18F-FDG PET/CT exam and 24h after a 18F-FDG PET/CT preceded by a low carbohydrate diet with 12h fasting
Other: Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT
The patients will receive 2 PET/CT , first exam with standard diet preceded by 12h fasting and second exam preceded by 3 meals strict low diet and 12h fasting
Also known as: 18F-FDG PET/CT
Infectious focus 18F-FDG activity measured with SUV (standardized uptake value )
The contrast will be measured thanks to the ratio SUV (standardized uptake value ) infectious focus and SUV (standardized uptake value ) surrounding tissue
Time frame: 24 hours
Visual analysis to detect and locate infective area
each infectious focus will be appreciated by visual reading
Time frame: 24 hours
SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)
Measure of 18F-FDG activity on the target organs
Time frame: 3 days
metabolic biomarker assay: ß-hydroxybutyrate
impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L)
Time frame: one week (on PET standard and on PET with Atkins diet)
Plan to share: No
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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