Clinical trial NCT01019200: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Cardiovascular Diseases
Dyslipidemia
Keywords: psoriasis
heart disease
cardiovascular disease
hyperlipidemia
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: After consent is obtained
Secondary outcomes:
measure: Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls.
timeFrame: After consent is obtained.
measure: Identify if an association exists between the extent and severity of psoriasis and measured lipid levels
timeFrame: After consent is obtained
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Dermatology Clinic
state: District of Columbia
Study officials:
affiliation: GWU
name: Alison Ehrlich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GWU
name: Lisa W Martin, MD
role: STUDY_CHAIR
affiliation: GWU
name: Monica Rengifo-Pardo
role: STUDY_CHAIR
References: