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

NCT01019200 | Completed

• 1 other identifier: IRB#100940
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis; Cardiovascular Diseases; Dyslipidemia

Keywords

psoriasis; heart disease; cardiovascular disease; hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Dermatology Clinic

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases; Dyslipidemias; Heart Diseases; Hyperlipidemias

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alison Ehrlich, MD

  GWU

  PRINCIPAL INVESTIGATOR

• Lisa W Martin, MD

  GWU

  STUDY CHAIR

• Monica Rengifo-Pardo

  GWU

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)