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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01019200
First received: November 23, 2009
Last updated: April 25, 2014
Last verified: January 2014

November 23, 2009
April 25, 2014
November 2009
July 2014   (final data collection date for primary outcome 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. [ Time Frame: After consent is obtained ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019200 on ClinicalTrials.gov Archive Site
  • Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls. [ Time Frame: After consent is obtained. ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
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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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

  • Psoriasis
  • Cardiovascular Diseases
  • Dyslipidemia
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Sirlekar Bullocks 202-741-6141 sbullocks@mfa.gwu.edu
United States
 
NCT01019200
IRB#100940
No
George Washington University
George Washington University
Not Provided
Principal Investigator: Alison Ehrlich, MD GWU
Study Chair: Lisa W Martin, MD GWU
Study Chair: Jack Short, MD GWU
George Washington University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP