Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study (MMAPPS)
2017年3月15日 更新者：Steven K. Grinspoon, MD、Massachusetts General Hospital
The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.
研究概览
地位
终止
条件
详细说明
Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis.
Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease.
This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.
研究类型
观察性的
注册 (实际的)
29
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.
描述
FOR PSORIASIS PATIENTS
Inclusion Criteria:
-men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly
Exclusion Criteria:
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
- previous therapy for psoriasis with a biologic agent within the past 4 months
- new initiation of a statin or antihyperglycemic agent within the past 3 months
- screening hemoglobin < 11
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an eGFR by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (uninterruptable administration of phosphodiesterase inhibitors), body weight greater than 320 lbs (PET scanner table limitation)
report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
FOR HEALTHY CONTROL SUBJECTS
Inclusion Criteria:
-men and women age 18-80 without psoriasis
Exclusion Criteria:
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease
- screening hemoglobin < 11
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an estimated creatinine clearance by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (e.g. continuous administration of phosphodiesterase inhibitors), body weight greater than 320 lbs PET scanner table limitation)
report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Healthy control subjects
Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline.
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Psoriasis patients starting etanercept
Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Morphology of the aortic/coronary atherosclerotic plaque (e.g.
calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Endothelial function as measured by flow-mediated vasodilation.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Oral glucose tolerance.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Lipid and lipoprotein levels.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Inflammatory biomarker levels.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Body fat distribution.
大体时间：Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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Measurements of height, weight, waist-to-hip ratio, leg circumference, arm circumference, and neck circumference.
Determinations by whole body DEXA scanning of the total body and regional percent fat and lean body mass.
Determination by single-slice abdominal computed tomography of total fat area, visceral adipose tissue, and subcutaneous adipose tissue.
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Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Steven K Grinspoon, MD、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年2月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2011年12月29日
首先提交符合 QC 标准的
2012年1月30日
首次发布 (估计)
2012年2月1日
研究记录更新
最后更新发布 (实际的)
2017年3月17日
上次提交的符合 QC 标准的更新
2017年3月15日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.