Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis

Official Title: “A Case Control Study to Evaluate Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis.”

Psoriasis patients are known to be at increased risk for heart disease. This may be due to the increased prevalence of cardiovascular disease risk factors in this population, including high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are known to be altered in psoriasis, most studies have used standard lipid profiles to measure cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate when triglyceride levels are high, as often see in individuals with psoriasis. We have designed a case-control study that uses a more specific and detailed cholesterol test to measure serum lipid levels in psoriasis patients, allowing for more accurate determination of LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also measure other markers of inflammation that may contribute to cardiovascular disease.

Arms, Groups and Cohorts in this Clinical Trial

• : Psoriasis
  • Individuals with a diagnosis of psoriasis as confirmed by the principle investigator will comprise the psoriasis or case group. Participants must meet inclusion and exclusion criteria as defined below. This group will consist of 100 individuals.
• : Control
  • Individuals without psoriasis, but meeting inclusion and exclusion criteria, will be selected to be within the control group. For each patient with psoriasis within the psoriasis group, an age, sex, and BMI-matched control will be selected. The group will consist of 100 individuals.

Primary Measures

• Evaluate differences in serum lipid levels in psoriasis patients compared to controls through the use of a relatively new comprehensive lipid profile test that has not been used in previous psoriasis studies.
  • Time Frame: After consent is obtained
    Safety Issue?: No

Secondary Measures

• Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls.
  • Time Frame: After consent is obtained.
    Safety Issue?: No
• Identify if an association exists between the extent and severity of psoriasis and measured lipid levels
  • Time Frame: After consent is obtained
    Safety Issue?: No

Inclusion Criteria:

• Adults of both sexes from our dermatology clinic, between the age 18 and 80 years who wish to participate voluntarily in the study and who have signed a written informed consent form to participate. Cases will have a diagnosis of psoriasis as diagnosed by our principal investigator, while controls will be selected from the same dermatology clinic.

Exclusion Criteria:

• Current or past use (within 6-8 weeks) of anti-hyperlipidemic agents (statins, fibrates, neomycin, niacin, ezetimibe) and/or any other medications significantly affecting lipid metabolism, including cyclosporine, acitretin, protease inhibitors, tamoxifen, clozapine, and estrogen replacement therapy.
• Presence of secondary causes of hyperlipidemia including diabetes mellitus, smoking, untreated hypothyroidism, nephrotic syndrome, chronic kidney disease, and cholestatic liver disease (e.g. primary biliary cirrhosis).
• History of cardiovascular disease (e.g. previous myocardial infarction, stroke, or angioplasty performed secondary to atherosclerosis).
• History of alcohol intake >30 g/day in males and >20 g/day in females.
• Pregnancy
• Subjects with conditions or diseases hindering data collection and follow up, such as incapacitating diseases, cognitive deterioration, institutionalized patients.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: George Washington University Other

Overall Clinical Trial Officials and Contacts

Alison Ehrlich, MD Principal Investigator GWU  

Overall Contact: Amir Zahir, MD 202-741-2632 azahir@mfa.gwu.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01019200

Study ID Number: IRB#100940

ClinicalTrials.gov Identifier: NCT01019200

Health Authority: United States: Institutional Review Board