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    The study has been updated to version v2.10.0, with three locations now included, replacing the previous version v2.9.7.
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    Summary
    The value 'Show more Show more Show more Revision: v2.9.0' has recently changed to 'Show less Show less MedlinePlus related topics: Atherosclerosis Diagnostic Imaging Drug Information available for: Methotrexate FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Double ( Participant Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Low dose methotrexate average dose of 15-20 mg po/weekly Drug : Low dose methotrexate Study participants will additionally receive 1 mg daily oral folate. Placebo Comparator : Placebo matching placebo Drug : Placebo Primary Outcome Measures Outcome Measure Measure Description Time Frame Change in Arterial Inflammation Change in arterial inflammation - The relative change at 8 months as compared to baseline in arterial inflammation as measured by the most diseased segment (MDS) of the index vessel. The MDS is defined as the 1.5 cm segment within the carotid artery (right or left carotid) that demonstrates the highest PET/CT activity, and is calculated as a mean of maximum TBR values derived from 3 contiguous axial segments. The index vessel in turn is defined as the vessel (either aorta, right, or left carotid) with the greatest mean TBR at baseline. (MDS TBR Index Vessel) baseline and 8 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Change in Max Target-to-background (TBR) Change in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid) at follow up imaging as compared to baseline. baseline and 8 months Change in Max TBR Within the Carotid Arteries Change in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid) baseline and 8 months Keywords Provided by Zahi Fayad, Icahn School of Medicine at Mount Sinai Atherosclerotic cardiovascular disease Inflammation reduction Additional Relevant MeSH Terms Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Atherosclerosis Inflammation Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Methotrexate Study Documents Provided by Zahi Fayad, Icahn School of Medicine at Mount Sinai Study Protocol and Statistical Analysis Plan [ PDF , 1.18MB, 2019-03-07 ] Revision: v2.9.1'
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    Check dated 2024-06-25T08:26:02.000Z thumbnail image

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