Expired Study
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Cleveland, Ohio 44106


Purpose:

This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events. The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time. Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.


Criteria:

Inclusion Criteria: - Subjects ages 18-65 years old - Diagnosis of moderate-to-severe plaque psoriasis - Plaque affects ≥ 10% of subject's body surface area (BSA) - Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin - Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment): - Discontinue systemic therapies for at least 4 weeks - Discontinue topical therapies for at least 2 weeks - Discontinue phototherapies for at least 2 weeks Exclusion Criteria: - Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period - Subjects with a critical illness or who are immunocompromised - Weight is 400lbs or greater - Subjects who are currently pregnant or breastfeeding - Subjects who have metal implants - Subjects who have a pacemaker, stent, or artificial heart valve - History of clinically significant hematological, renal or liver disease - Patients with known co-morbidities that raise biomarkers such as: - History of myocardial infarction (MI) - History of cerebrovascular accident (CVA) - Significant atherosclerosis (defined as the presence of any carotid plaque; or carotid intimal media thickness (cIMT) >75th percentile for age; or the presence of coronary artery calcium score>100) - Poorly controlled diabetes (elevated HbA1c > 8.5)


NCT ID:

NCT02330380


Primary Contact:

Principal Investigator
Neil Korman, MD
University Hospitals Cleveland Medical Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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