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
  Purpose

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
Psoriasis
Cardiovascular Diseases
Dyslipidemia

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019200

Contacts
Contact: Sirlekar Bullocks 202-741-6141 sbullocks@mfa.gwu.edu

Locations
United States, District of Columbia
The George Washington University Dermatology Clinic Recruiting
Washington, District of Columbia, United States, 20037
Contact: Alison Ehrlich, MD    202-741-2600      
Principal Investigator: Alison Ehrlich, MD         
Sub-Investigator: Lisa W Martin, MD         
Sub-Investigator: Amir Zahir, MD         
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Alison Ehrlich, MD GWU
Study Chair: Lisa W Martin, MD GWU
Study Chair: Jack Short, MD GWU
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01019200     History of Changes
Other Study ID Numbers: IRB#100940
Study First Received: November 23, 2009
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
psoriasis
heart disease
cardiovascular disease
hyperlipidemia

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

ClinicalTrials.gov processed this record on September 22, 2014