Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Study Overview
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Brief Summary
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A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

Detailed Description
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Research design: A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, without other chronic diseases, treated with five different types of treatment (local therapy, methotrexate, inhibitor of tumor necrosis factor α, inhibitor of interleukin 17 and inhibitor of interleukin 23), and 20 healthy patients aged 30-45 years. All 100 subjects will be subjected to anthropometric measurements (measurement of weight, height, systolic and diastolic blood pressure, heart rate, waist circumference), blood will be collected for laboratory tests (full blood count with differential, CRP, serum electrolytes, lipid panel, fasting glucose, HbA1c, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, TNF-alpha, IL-6, IL-12, IL-17, IL-23, hsCRP, IFN-gamma, TRANCE, TRAIL, GDF-15, D-dimer, fibrinogen, overall haemostasis potential, overall coagulation potential, VCAM-1, ECAMs), and an imaging test (flow-mediated dilation and measurement of pulse wave velocity) will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed. Aim of the study: The impact of chronic systemic inflammation in psoriasis on subclinical defects in the cardiovascular system (endothelial dysfunction, arterial stiffness, insulin resistance, platelet activation, and coagulation activation) and their effects on each other will be studied. In addition, the effect of the five main types of psoriasis treatment on all listed subclinical defects of the cardiovascular system will be investigated. Moreover, it will be investigated whether the type of treatment affects systemic inflammation in psoriasis in the same manner. Expected results: It is expected that all five groups of patients will differ from each other in terms of the degree of subclinical impairment of the cardiovascular system, depending on the expression of psoriasis and the type of treatment they receive. This will form the basis for establishing preventive measures against cardiovascular diseases in patients with psoriasis.

Official Title
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Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Conditions
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Psoriasis, Inflammation, Endothelial Dysfunction, Metabolic Disturbance, Insulin Resistance, Coagulation Disorder, Thrombocyte Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months Exclusion Criteria: any treatment besides treatment of psoriasis carotid disease heart failure atrial fibrillation diabetes type 1 or 2 cardiovascular event in the past chronic kidney disease stage 3, 4, 5 or end-stage kidney disease psoriatic arthritis or any other rheumatic disease malignancy menopause in women other chronic inflammatory diseases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on local therapy<br>20 patients on local antipsoriatic therapy (either corticosteroid cream/ointment, calcipotriol or combination (corticosteroid and calcipotriol); duration of treatment varies in cohort of patients | |
| Patients on methotrexate<br>20 patients on methotrexate with dosage adjusted by weight; duration of treatment varies in cohort of patients | |
| Patients on biologic therapy with anti-tumor necrosis factor-alpha<br>20 patients on adalimumab - 40 mg every two weeks (or 40 mg weekly if the response was previously insufficient); duration of treatment varies in cohort of patients | |
| Patients on biologic therapy with anti-interleukin-17<br>20 patients on secukinumab - 300 mg monthly (or 300 mg every two weeks if the response was previously insufficient); duration of treatment varies in cohort of patients | |
| Patients on biologic therapy with anti-interleukin-23<br>20 patients on guselkumab - 100 mg every 8 weeks; duration of treatment varies in cohort of patients | |
| Controls<br>20 subjects who are age-matched | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial function - endothelial function | Endothelial function (flow-mediated dilation) | through study completion, an average of 6 months | 
| Arterial function - arterial stiffness | Arterial stiffness (pulse wave velocity) | through study completion, an average of 6 months | 
| Endothelial activation | Circulating markers of endothelial activation (E-selectin, vascular cell adhesion molecule-1 (VCAM-1), Endothelial cell adhesion molecules (ECAMs)) | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Circulating markers of inflammation (tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6, IL-12, IL-17, IL-23, high sensitivity C-reactive protein (hs-CRP), interferon-gamma, TNF-related activation-inducing ligand (TRANCE), TNF-related apoptosis-inducing ligand (TRAIL), Growth/differentiation factor-15 (GDF-15), neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR)) | through study completion, an average of 6 months | 
| Insulin resistance | Circulating markers of insulin resistance (fasting glucose, insulin), HOMA-IR equation (Homeostatic Model Assessment for Insulin Resistance) | through study completion, an average of 6 months | 
| Metabolic disturbances - dyslipidemia | Parameters of (pre)metabolic syndrome (lipid panel) | through study completion, an average of 6 months | 
| Metabolic disturbances | Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index)) | through study completion, an average of 6 months | 
| Liver steatosis | Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4)) | through study completion, an average of 6 months | 
| Coagulation | Circulating markers of coagulation activation (D-dimer, fibrinogen) | through study completion, an average of 6 months | 
| Activation of hemostasis | Hemostatic assay (overall hemostasis potential (OHP) assay) | through study completion, an average of 6 months | 
| Activation of coagulation | Coagulation assay (overall coagulation potential (OCP) assay) | through study completion, an average of 6 months | 
| Platelet activation (1) | Circulating markers of platelet activation (mean platelet volume (MPV) | through study completion, an average of 6 months | 
| Platelet activation (2) | Circulating markers of platelet activation (P-selectin) | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Endothelial dysfunction, Inflammation, Insulin resistance, Biologic therapy