PaS: Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT05957120

Collaborator

(none)

100

Enrollment

Location

10.9

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Inflammation Endothelial Dysfunction Metabolic Disturbance Insulin Resistance Coagulation Disorder Thrombocyte Disorders

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Actual Study Start Date :

Jan 3, 2022

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients on local therapy 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 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 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 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 20 patients on guselkumab - 100 mg every 8 weeks; duration of treatment varies in cohort of patients
Controls 20 subjects who are age-matched

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammation [through study completion, an average of 6 months]
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))
Insulin resistance [through study completion, an average of 6 months]
Circulating markers of insulin resistance (fasting glucose, insulin), HOMA-IR equation (Homeostatic Model Assessment for Insulin Resistance)
Metabolic disturbances - dyslipidemia [through study completion, an average of 6 months]
Parameters of (pre)metabolic syndrome (lipid panel)
Metabolic disturbances [through study completion, an average of 6 months]
Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index))
Liver steatosis [through study completion, an average of 6 months]
Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4))
Coagulation [through study completion, an average of 6 months]
Circulating markers of coagulation activation (D-dimer, fibrinogen)
Activation of hemostasis [through study completion, an average of 6 months]
Hemostatic assay (overall hemostasis potential (OHP) assay)
Activation of coagulation [through study completion, an average of 6 months]
Coagulation assay (overall coagulation potential (OCP) assay)
Platelet activation (1) [through study completion, an average of 6 months]
Circulating markers of platelet activation (mean platelet volume (MPV)
Platelet activation (2) [through study completion, an average of 6 months]
Circulating markers of platelet activation (P-selectin)