View Clinical Trial (Medical Research Study)
Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Psoriasis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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 12 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
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| NCT ID: |
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NCT01522742 |
| Primary Contact: |
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Principal Investigator
Steven K Grinspoon, MD
Massachusetts General Hospital
Steven K Grinspoon, MD
Phone: 617-724-9109
Email: sgrinspoon@partners.org
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| Backup Contact: |
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Email: mzanni@partners.org
Markella V Zanni, MD
Phone: 617-724-6926
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| Location Contact: |
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Boston, Massachusetts 02114
United States
Steven K Grinspoon, MD
Phone: 617-724-9109
Email: sgrinspoon@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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