PsoriasisNCT01019200
Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis
An observational study of Psoriasis and Cardiovascular Diseases, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Cardiovascular Diseases, Dyslipidemia
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Dermatology Clinic
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
- Conditions
- Psoriasis, Cardiovascular Diseases, Dyslipidemia
- Keywords
- psoriasis, heart disease, cardiovascular disease, hyperlipidemia
- Medical subject headings
- Psoriasis, Cardiovascular Diseases, Dyslipidemias, Heart Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After consent is obtained
Secondary outcomes (2)
Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls.
Measured: After consent is obtained.
Identify if an association exists between the extent and severity of psoriasis and measured lipid levels
Measured: After consent is obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Ehrlich, MD, Principal investigator, GWULisa W Martin, MD, Study chair, GWUMonica Rengifo-Pardo, Study chair, GWU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019200
- Sponsor's protocol ID
- IRB#100940
- Status last verified
- Feb 2016
- First submitted
- 23 Nov 2009
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study to Evaluate Serum Lipid Levels and Other Biomarkers of Cardiovascular Disease in Patients With Psoriasis.
- ClinicalTrials.gov ID
- NCT01019200
- Acronym / sponsor ID
- IRB#100940
- Conditions
- Psoriasis, Cardiovascular Diseases, Dyslipidemia
- Keywords
- psoriasis, heart disease, cardiovascular disease, hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the Dermatology Clinic at George Washington University Medical Faculty Associates.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Compare other cardiovascular biomarkers such as high-sensitivity C-Reactive Protein in psoriasis patients verses controls.
Time frame: After consent is obtained.
Identify if an association exists between the extent and severity of psoriasis and measured lipid levels
Time frame: After consent is obtained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: Yes
Related trials for Psoriasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Ehrlich, MD principal investigator
GWU
Lisa W Martin, MD study chair
GWU
Monica Rengifo-Pardo study chair
GWU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Cardiovascular Diseases, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.