Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Inflammation Clinical Trial

— PaS  

Official title:

Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957120
• Other study ID #: PICANTI
• Status: Completed
• Start date: January 3, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Platelet Disorders
• Coagulation Disorder
• Endothelial Dysfunction
• Hemostatic Disorders
• Inflammation
• Insulin Resistance
• Metabolic Disturbance
• Psoriasis

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial function - endothelial function	Endothelial function (flow-mediated dilation)	through study completion, an average of 6 months
Primary	Arterial function - arterial stiffness	Arterial stiffness (pulse wave velocity)	through study completion, an average of 6 months
Primary	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	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
Secondary	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
Secondary	Metabolic disturbances - dyslipidemia	Parameters of (pre)metabolic syndrome (lipid panel)	through study completion, an average of 6 months
Secondary	Metabolic disturbances	Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index))	through study completion, an average of 6 months
Secondary	Liver steatosis	Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4))	through study completion, an average of 6 months
Secondary	Coagulation	Circulating markers of coagulation activation (D-dimer, fibrinogen)	through study completion, an average of 6 months
Secondary	Activation of hemostasis	Hemostatic assay (overall hemostasis potential (OHP) assay)	through study completion, an average of 6 months
Secondary	Activation of coagulation	Coagulation assay (overall coagulation potential (OCP) assay)	through study completion, an average of 6 months
Secondary	Platelet activation (1)	Circulating markers of platelet activation (mean platelet volume (MPV)	through study completion, an average of 6 months
Secondary	Platelet activation (2)	Circulating markers of platelet activation (P-selectin)	through study completion, an average of 6 months