Chru Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
NCT Number: NCT03465098
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:
1. Comparison of the detection sensitivity of IE outbreaks between 18F-FDG PET/CT performed with the low carbohydrate diet and conventional diet performed 2. To assess the strict low carbohydrate diet effects on the uptake 18F-FDG distribution , particularly in the myocardium, circulating blood, skeletal muscles, brain and liver. 3. Characterization of metabolic changes generated by the low carbohydrate diet using plasma bioassays (blood glucose, insulinemia, free fatty acid concentration, ß-hydroxybutyrate).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vandœuvre-lès-Nancy, 54511, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 18F-FDG PET/CT
Time frame: 24 hours
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
each infectious focus will be appreciated by visual reading
Time frame: 3 days
Measure of 18F-FDG activity on the target organs
Time frame: one week (on PET standard and on PET with Atkins diet)
impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L)
Central Hospital, Nancy, France
Other
Evaluation of a Low-Carbohydrate Diet to Highlight Easily Infective Endocarditis by 18F-FDG PET
Acronym: TEPEIR
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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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