Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis
This study is currently recruiting participants.
Verified October 2011 by George Washington University
Sponsor:
George Washington University
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01019200
First received: November 23, 2009
Last updated: March 11, 2013
Last verified: October 2011
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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 |
|---|
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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 |
|---|
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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.
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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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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019200
Contacts
| Contact: Amir Zahir, MD | 202-741-2632 | azahir@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: | Amir Zahir, 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: | March 11, 2013 |
| 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 Psoriasis Dyslipidemias Skin Diseases, Papulosquamous |
Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013