Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
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.
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.
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:
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:
concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding