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Completed

NCT Number: NCT05957120

Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

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.

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Key information

Conditions

Psoriasis Blood Platelet Disorders Cardiovascular Diseases Coagulation Disorder Endothelial Dysfunction Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Disturbance Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Thrombocyte Disorders Vascular Diseases

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Arterial function - endothelial function

    Time frame: through study completion, an average of 6 months

    Endothelial function (flow-mediated dilation)

  2. Arterial function - arterial stiffness

    Time frame: through study completion, an average of 6 months

    Arterial stiffness (pulse wave velocity)

  3. Endothelial activation

    Time frame: 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 outcomes

  1. Inflammation

    Time frame: 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))

  2. Insulin resistance

    Time frame: 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)

  3. Metabolic disturbances - dyslipidemia

    Time frame: through study completion, an average of 6 months

    Parameters of (pre)metabolic syndrome (lipid panel)

  4. Metabolic disturbances

    Time frame: through study completion, an average of 6 months

    Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index))

  5. Liver steatosis

    Time frame: through study completion, an average of 6 months

    Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4))

  6. Coagulation

    Time frame: through study completion, an average of 6 months

    Circulating markers of coagulation activation (D-dimer, fibrinogen)

  7. Activation of hemostasis

    Time frame: through study completion, an average of 6 months

    Hemostatic assay (overall hemostasis potential (OHP) assay)

  8. Activation of coagulation

    Time frame: through study completion, an average of 6 months

    Coagulation assay (overall coagulation potential (OCP) assay)

  9. Platelet activation (1)

    Time frame: through study completion, an average of 6 months

    Circulating markers of platelet activation (mean platelet volume (MPV)

  10. Platelet activation (2)

    Time frame: through study completion, an average of 6 months

    Circulating markers of platelet activation (P-selectin)

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Acronym: PaS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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