Subclinical Impairment of Cardiovascular System in Patients With Psoriasis (PaS)

July 19, 2023 updated by: Eva Klara Merzel Šabović, University Medical Centre Ljubljana
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

5 groups of patients with psoriasis that are treated in our hospital with either local treatment, methotrexate, adalimumab, secukinumab or guselkumab will be included in the study. Included patients will be aged 30 to 45 years and will be without other chronic disease besides psoriasis and without other treatment besides antipsoriatic treatment to investigate the isolated effect of psoriasis on observed parameters (endothelial function, endothelial activation, inflammation, insulin resistance, metabolic disturbances, activation of coagulation and activation of platelets).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial function - endothelial function
Time Frame: through study completion, an average of 6 months
Endothelial function (flow-mediated dilation)
through study completion, an average of 6 months
Arterial function - arterial stiffness
Time Frame: through study completion, an average of 6 months
Arterial stiffness (pulse wave velocity)
through study completion, an average of 6 months
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))
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
through study completion, an average of 6 months
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)
through study completion, an average of 6 months
Metabolic disturbances - dyslipidemia
Time Frame: through study completion, an average of 6 months
Parameters of (pre)metabolic syndrome (lipid panel)
through study completion, an average of 6 months
Metabolic disturbances
Time Frame: through study completion, an average of 6 months
Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index))
through study completion, an average of 6 months
Liver steatosis
Time Frame: through study completion, an average of 6 months
Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4))
through study completion, an average of 6 months
Coagulation
Time Frame: through study completion, an average of 6 months
Circulating markers of coagulation activation (D-dimer, fibrinogen)
through study completion, an average of 6 months
Activation of hemostasis
Time Frame: through study completion, an average of 6 months
Hemostatic assay (overall hemostasis potential (OHP) assay)
through study completion, an average of 6 months
Activation of coagulation
Time Frame: through study completion, an average of 6 months
Coagulation assay (overall coagulation potential (OCP) assay)
through study completion, an average of 6 months
Platelet activation (1)
Time Frame: through study completion, an average of 6 months
Circulating markers of platelet activation (mean platelet volume (MPV)
through study completion, an average of 6 months
Platelet activation (2)
Time Frame: through study completion, an average of 6 months
Circulating markers of platelet activation (P-selectin)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Eva Klara Merzel Sabovic, MD, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

June 18, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICANTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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