PsoriasisNCT00893126
Premature Coronary Artery Disease (CAD) in Severe Psoriasis
An observational study of Psoriasis and Coronary Artery Disease, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Coronary Artery Disease
- What is being tested?
- CCTA Scan (Coronary CT Angiogram)
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with severe psoriasis will be selected prospectively from the clinics of the University of Michigan, Dept. of Dermatology. The comparison group (subjects without psoriasis) will be targeted in the Dermatology clinic by screening for matching variables before enrollment. This group will be matched by age and gender to the psoriasis population, and on Framingham risk score.
Who may be able to join
- Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
- Male or female ages 18 to 55 (because CAD risk has been shown to be greatest in younger psoriasis patients in earlier studies, this pilot study will focus on young individuals).
- Able to give informed consent
Who cannot join
- Prior diagnosis of CAD (coronary artery disease) or heart disease based upon one or more of the following:
- coronary arteriography
- percutaneous coronary intervention
- cardiac surgery including bypass graft surgery
- valve surgery
- congenital heart disease repair
Show all 22Show fewer
- stress ECG or imaging
- myocardial infarction
- angina or unstable angina
- congestive heart failure
- cardiomyopathy
- History of anti-oxidants such as fish oil or biologic therapy Tumor Necrosis Factor alpha inhibitors (such as etanercept, adalimumab, or infliximab). A recent review by Sattar et al [22] has shown preliminary evidence that TNF (tumor necrosis factor) blockade can modulate nontraditional cardiovascular risk factors such as C-reactive protein(CRP), Interleukin-6(IL-6), Apolipoprotein AI(ApoAI), Lipoprotein(a)(Lp[a]), Sex Hormone Binding Globulin (SHBG), and homocysteine to exert a possible vascular and metabolic protective effect.
- Pustular and erythrogenic psoriasis
- Unable to give informed consent
- Contraindications to coronary CT, including:
- Irregular heart rate, such as multiple PVCs (premature ventricular contractions), atrial fibrillation
- Active heart failure
- Serum creatinine > 1.5mg/dl
- Weight > 320 lbs (due to degradation in CT (computerized tomography)image quality by image noise)
- History of severe allergy to intravenous contrast media
- High irregular heart rate with contraindications to beta-blockers
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors.
Read the detailed description
To establish the relationship between psoriasis and coronary disease by comparing the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors, as determined by CT coronary calcium scoring and Coronary CT angiography.
- Conditions
- Psoriasis, Coronary Artery Disease
- Being tested
- CCTA Scan (Coronary CT Angiogram)
- Keywords
- psoriasis, coronary arteriosclerosis, coronary events, rheumatoid arthritis, arthritis
- Medical subject headings
- Psoriasis, Coronary Artery Disease, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA Scan (Coronary CT Angiogram)Procedure or surgery
CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with severe psoriasis | Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan. Receives: Procedure: CCTA Scan (Coronary CT Angiogram) | |
| Subjects without psoriasis | Subjects 18 to 55 who do not have psoriasis or rheumatologic conditions, including rheumatoid arthritis and systemic lupus erythematosus. This group of subjects will complete a CCTA (Coronary CT Angiogram)scan. Receives: Procedure: CCTA Scan (Coronary CT Angiogram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the relationship between psoriasis and coronary disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2016
- Study completionAug 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 University of MichiganThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prachi P Agarwal, M.D., University of Michigan
- Investigators
- Prachi P Agarwal, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893126
- Sponsor's protocol ID
- HUM00020514
- Status last verified
- Oct 2016
- First submitted
- 1 May 2009
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Coronary Artery Disease (CAD) in Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00893126
- Acronym / sponsor ID
- HUM00020514
- Conditions
- Psoriasis, Coronary Artery Disease
- Keywords
- psoriasis, coronary arteriosclerosis, coronary events, rheumatoid arthritis, arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 May 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.
The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors.
Detailed description
To establish the relationship between psoriasis and coronary disease by comparing the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors, as determined by CT coronary calcium scoring and Coronary CT angiography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe psoriasis | – | Procedure: CCTA Scan (Coronary CT Angiogram)Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan. |
| Subjects without psoriasis | – | Procedure: CCTA Scan (Coronary CT Angiogram)Subjects 18 to 55 who do not have psoriasis or rheumatologic conditions, including rheumatoid arthritis and systemic lupus erythematosus. This group of subjects will complete a CCTA (Coronary CT Angiogram)scan. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with severe psoriasis will be selected prospectively from the clinics of the University of Michigan, Dept. of Dermatology. The comparison group (subjects without psoriasis) will be targeted in the Dermatology clinic by screening for matching variables before enrollment. This group will be matched by age and gender to the psoriasis population, and on Framingham risk score.
Key inclusion criteria (3 listed)
- Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
- Male or female ages 18 to 55 (because CAD risk has been shown to be greatest in younger psoriasis patients in earlier studies, this pilot study will focus on young individuals).
- Able to give informed consent
Key exclusion criteria (22 listed)
- Prior diagnosis of CAD (coronary artery disease) or heart disease based upon one or more of the following:
- History of anti-oxidants such as fish oil or biologic therapy Tumor Necrosis Factor alpha inhibitors (such as etanercept, adalimumab, or infliximab). A recent review by Sattar et al [22] has shown preliminary evidence that TNF (tumor necrosis factor) blockade can modulate nontraditional cardiovascular risk factors such as C-reactive protein(CRP), Interleukin-6(IL-6), Apolipoprotein AI(ApoAI), Lipoprotein(a)(Lp[a]), Sex Hormone Binding Globulin (SHBG), and homocysteine to exert a possible vascular and metabolic protective effect.
- Pustular and erythrogenic psoriasis
- Unable to give informed consent
- Contraindications to coronary CT, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA Scan (Coronary CT Angiogram)CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD). | Procedure or surgery | Subjects with severe psoriasis, Subjects without psoriasis |
Primary outcome
To establish the relationship between psoriasis and coronary disease
Time frame: 1 year
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 19 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Prachi P Agarwal, M.D. principal investigator
University of Michigan Hospital
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 Coronary Artery Disease, run by University of Michigan 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 3 inclusion and 22 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 19 Oct 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?
To establish the relationship between psoriasis and coronary disease (time frame: 1 year). 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 19 Oct 2016.