Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
时间窗: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
次要结局
- Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Inflammatory biomarker levels.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Lipid and lipoprotein levels.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Endothelial function as measured by flow-mediated vasodilation.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Oral glucose tolerance.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
- Body fat distribution.(Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).)
研究者
Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Massachusetts General Hospital