Clinical trial NCT00893126: Premature Coronary Artery Disease (CAD) in Severe Psoriasis
Official title: Premature Coronary Artery Disease (CAD) in Severe Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Coronary Artery Disease
Keywords: psoriasis
coronary arteriosclerosis
coronary events
rheumatoid arthritis
arthritis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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
   * cardiomyopathy
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 \[22\] 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.
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
   * Pregnant

Primary outcomes:
measure: To establish the relationship between psoriasis and coronary disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Prachi P Agarwal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: