NL-OMON36115已完成不适用
Vascular Inflammation in Patients at Risk for Atherosclerotic Disease - VIPER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria
- •Subjects at risk
- •Patients must meet the following criteria for study entry:
- •1) Patients aged equal to or greater than (*) 50 years.
- •2) Patients with an increased risk for cardiovascular disease, as determined by one of the following risk factors:
- •a) LP(a) > 1200 mg/dl (> 90th percentile)
- •b) Reduced High density lipoprotein (< 10th percentile for age and sex),
- •c) Increased LDL cholesterol (LDL > 90th percentile for age and sex)
- •Age and sex adjusted percentiles tables for LDL and HDL are provided in appendix A.
- •3) If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance.
- •4) For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to baseline measurement.
- •5) Stable Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs) for at least 6 weeks prior to baseline measurement.
- •6) Subject agrees to the restrictions as described in paragraph 4.6. 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.;Healthy controls
- •Healthy controls must meet the following criteria for study entry:
- •1) Healthy subjects aged > 50 years of age.
- •2) Subjects with baseline levels of the following risk factors between the 35 - 65th percentile.
- •b) High density lipoprotein
- •c) LDL cholesterol
- •3) No use of systemic medication
- •4) No history of cardiovascular disease
- •5) Subject agrees to the restrictions as described in paragraph 4.6. 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.
排除标准
- •Subjects may not enter this study if they meet the following criteria: ;1) Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy.
- •2) Use medication for diabetes mellitus, of hypertension.
- •3) Are known with a BMI > 28.
- •4) 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:
- •* Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled steroids).
- •* 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
- •* No other Disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.)
- •5) Any clinically significant medical condition that could interfere with the conduct of the study.
- •6) Standard contra-indications to MRI, 18FDG PET, and CT.
- •7) Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- •8) 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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