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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Psoriasis; Dyslipidemia

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	After consent is obtained

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls.	After consent is obtained.
Identify if an association exists between the extent and severity of psoriasis and measured lipid levels	After consent is obtained

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Alison Ehrlich, MD, GWU; Study Chair: Lisa W Martin, MD, GWU; Study Chair: Monica Rengifo-Pardo, GWU

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 23, 2009
• First Posted (ESTIMATE): November 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: cardiovascular disease; psoriasis; heart disease; hyperlipidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Skin Diseases, Papulosquamous; Lipid Metabolism Disorders; Cardiovascular Diseases; Psoriasis; Dyslipidemias
• Other Study ID Numbers: IRB#100940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES