Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 30, 2012

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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