The risk of cardiovascular disease in Ankylosing Spondylitis; A Single Center Cross-Sectional Study Evaluating The Association Between Inflammation In Ankylosing Spondylitis And Vascular Inflammation - AS risk

AMC0 个研究点开始时间: 2013年8月15日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•Subjects with AS
•?Age: =18 years
•?Diagnosis of AS (following the 1984 Modified New York Criteria for ankylosing Spondylitis (16)) + disease duration since start of first symptoms for a period of more than 3 years.
•?Subject agrees to the restrictions as described in paragraph 4.4.2. In brief: subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects may not enter this study if they meet the following criteria
•?BMI > 30.
•?History of diabetes mellitus/insulin use
•?Hypertension/use of blood pressure lowering medication
•?Use of statins prior to inclusion, or contra-indications for statin use.
•?History of cardiovascular events
•?Proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing
•?Serious infection requiring IV antibiotic therapy.
•?Recent or current treatment with medications that may have a significant effect on plaque Inflammation as measured by plaque TBR, including but not limited to: Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study.
•?Any clinically significant medical condition that could interfere with the conduct of the study.
•?Standard contra-indications to MRI, 18FDG PET, and CT, including pregnancy and lactating women.
•?Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
•?Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.

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