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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019200
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : June 16, 2016
Information provided by (Responsible Party):
George Washington University

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.

Condition or disease
Psoriasis Cardiovascular Diseases Dyslipidemia

Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Case Control Study to Evaluate Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis.
Study Start Date : November 2009
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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.
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 Outcome Measures :
  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. [ Time Frame: After consent is obtained ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01019200

United States, District of Columbia
The George Washington University Dermatology Clinic
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Principal Investigator: Alison Ehrlich, MD GWU
Study Chair: Lisa W Martin, MD GWU
Study Chair: Monica Rengifo-Pardo GWU

Responsible Party: George Washington University Identifier: NCT01019200     History of Changes
Other Study ID Numbers: IRB#100940
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by George Washington University:
heart disease
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases