PsoriasisNCT01382784
Psoriasis and the Risk of Cardiovascular Disease. A Prospective Study
An observational study of Psoriasis and Cardiovascular Disease, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Cardiovascular Disease
- How many people
- 100 participants
- Where
- 2 sitesNorway
- Study dates
- May 2011to not given
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have had psoriasis for more than 5 years are being admitted to the study. The assessments include: clinical data, treatment, platelet aggregation and blood viscosity, serum markers and mediators of atherosclerosis, carotid IMT and plaque burden assessed by Color Duplex ultrasound. The patients are recruited from our dermatological department (in and outdoor patients)
Who may be able to join
- >18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (PASI >10 or systemic treatment)
Who cannot join
- familiar hypercholesterolemia, ongoing infections and cancer disease
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Dermatological Department, OUS
Oslo
Oslo university Hospital, Dermatological dept
Oslo
About this study
Official title: Psoriasis and the Risk of Cardiovascular Disease. A Prospective Observational Study to Detect Cardiovascular Risk Factors
There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. The main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.
- Conditions
- Psoriasis, Cardiovascular Disease
- Medical subject headings
- Psoriasis, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2011
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 Oslo University HospitalThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382784
- Sponsor's protocol ID
- Psoriasis and comorbidity
- Status last verified
- May 2011
- First submitted
- 24 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriasis and the Risk of Cardiovascular Disease. A Prospective Observational Study to Detect Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01382784
- Acronym / sponsor ID
- Psoriasis and comorbidity
- Conditions
- Psoriasis, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2011
- First posted
- 27 Jun 2011 (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.
There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. The main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had psoriasis for more than 5 years are being admitted to the study. The assessments include: clinical data, treatment, platelet aggregation and blood viscosity, serum markers and mediators of atherosclerosis, carotid IMT and plaque burden assessed by Color Duplex ultrasound. The patients are recruited from our dermatological department (in and outdoor patients)
Key inclusion criteria (1 listed)
- >18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (PASI >10 or systemic treatment)
Key exclusion criteria (1 listed)
- familiar hypercholesterolemia, ongoing infections and cancer disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Disease, run by Oslo University Hospital at 2 sites in Norway.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Results are not available in the source record.
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.
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 27 Jun 2011.