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Effects of Combined Vitamin K2 and Vitamin D3 Supplementation on Na[18F]F PET/MRI in Patients with Carotid Artery Disease: The INTRICATE Rationale and Trial Design.
Florea, Alexandru; Kooi, M Eline; Mess, Werner; Schurgers, Leon J; Bucerius, Jan; Mottaghy, Felix M.
Afiliación
  • Florea A; Department of Nuclear Medicine, University Hospital RWTH Aachen, 52074 Aachen, Germany.
  • Kooi ME; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.
  • Mess W; School for Cardiovascular Diseases (CARIM), Maastricht University, 6229HX Maastricht, The Netherlands.
  • Schurgers LJ; Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.
  • Bucerius J; School for Cardiovascular Diseases (CARIM), Maastricht University, 6229HX Maastricht, The Netherlands.
  • Mottaghy FM; Department of Clinical Neurophysiology, Maastricht University Medical Center, 6229HX Maastricht, The Netherlands.
Nutrients ; 13(3)2021 Mar 19.
Article en En | MEDLINE | ID: mdl-33808652
INTRICATE is a prospective double-blind placebo-controlled feasibility study, assessing the influence of combined vitamin K2 and vitamin D3 supplementation on micro-calcification in carotid artery disease as imaged by hybrid Sodium [18F]Fluoride (Na[18F]F) positron emission tomography (PET)/ magnetic resonance imaging (MRI). Arterial calcification is an actively regulated process and results from the imbalance between calcification promoting and inhibiting factors. Considering the recent advancements in medical imaging, ultrasound (US), PET/MRI, and computed tomography (CT) can be used for the selection and stratification of patients with atherosclerosis. Fifty-two subjects with asymptomatic carotid artery disease on at least one side of the neck will be included in the study. At baseline, an Na[18F]F PET/MRI and CT examination will be performed. Afterwards, subjects will be randomized (1:1) to a vitamin K (400 µg MK-7/day) and vitamin D3 (80 µg/day) or to placebo. At the 3-month follow-up, subjects will undergo a second Na[18F]F PET/MRI and CT scan. The primary endpoint is the change in Na[18F]F PET/MRI (baseline vs. after 3 months) in the treatment group as compared to the placebo arm. Secondary endpoints are changes in plaque composition and in blood-biomarkers. The INTRICATE trial bears the potential to open novel avenues for future large scale randomized controlled trials to intervene in the plaque development and micro-calcification progression.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades de las Arterias Carótidas / Colecalciferol / Suplementos Dietéticos / Vitamina K 2 / Tomografía de Emisión de Positrones Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies Idioma: En Revista: Nutrients Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades de las Arterias Carótidas / Colecalciferol / Suplementos Dietéticos / Vitamina K 2 / Tomografía de Emisión de Positrones Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies Idioma: En Revista: Nutrients Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Suiza