Subclinical Cardiovascular Disease in Psoriatic Disease

Study Overview
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Brief Summary
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This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.

Detailed Description
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Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.

Official Title
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Subclinical Cardiovascular Disease in Psoriatic Disease

Conditions
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Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease, Thrombotic Vascular Disease

Intervention / Treatment
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* Drug: Aspirin and/or Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a history of moderate to severe psoriatic disease Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease Exclusion Criteria: Unable to speak Spanish or English Active smoking (within the past year) Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis Known active cancer receiving treatment Pregnancy Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600) A history of severe bleeding or bleeding disorders Current medication use which interact with either aspirin or atorvastatin Chronic kidney disease (CrCl < 30ml/min) Congestive heart failure Currently taking aspirin or a statin. NSAID use within the past 48 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Psoriatic Disease Patients<br>Moderate to severe psoriatic disease | Drug: Aspirin and/or Atorvastatin<br>* This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.<br>|
| No Intervention: Healthy Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript | Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation | Baseline, 5 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold Change Change in Composite Endothelial Inflammation | Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy | Baseline (pre-Aspirin), 2 weeks (post-Aspirin) | 
| Fold Change in Composite Endothelial Inflammation | Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy. | Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin) | 
| Change in Levels of Circulating Thromboxane B2 | Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy | Baseline (pre-Aspirin), 2 weeks (post-Aspirin) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, CVD