Official Title: “Premature Coronary Artery Disease (CAD) in Severe Psoriasis”
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.
- Study Type: Observational
- Study Design: Observational Model: Case Control, Time Perspective: Prospective
- Study Primary Completion Date: March 2016
Detailed Clinical Trial 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.
Interventions Used in this Clinical Trial
- Procedure: CCTA Scan (Coronary CT Angiogram)
- CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).
Arms, Groups and Cohorts in this Clinical Trial
- Subjects with severe psoriasis
- Subjects 18 to 55 with severe psoriasis. Subject will undergo a CCTA (Coronary CT Angiogram) scan.
- 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.
Outcome Measures for this Clinical Trial
- To establish the relationship between psoriasis and coronary disease
- Time Frame: 1 year
Safety Issue?: No
- Time Frame: 1 year
Criteria for Participation in this Clinical Trial
1. Patients with severe psoriasis as determined by more than two episodes of systemic or inpatient treatment and 10% or more body surface area involvement.
2. 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).
3. Able to give informed consent
1. 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
- stress ECG or imaging
- myocardial infarction
- angina or unstable angina
- congestive heart failure
2. 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  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.
3. Pustular and erythrogenic psoriasis
4. Unable to give informed consent
5. 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers
Clinical Trial Investigator Information
- Lead Sponsor
- University of Michigan
- Provider of Information About this Clinical Study
- Principal Investigator: Prachi P Agarwal, M.D., Principal Investigator – University of Michigan
- Overall Official(s)
- Prachi P Agarwal, M.D., Principal Investigator, University of Michigan Hospital