PsoriasisPaSNCT05957120
Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
An observational study of Psoriasis and Inflammation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Psoriasis, Inflammation, Endothelial Dysfunction
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Jan 2022to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months
Who cannot join
- any treatment besides treatment of psoriasis
- carotid disease
- heart failure
- atrial fibrillation
- diabetes type 1 or 2
- cardiovascular event in the past
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psoriasis, Inflammation, Endothelial Dysfunction, Metabolic Disturbance, Insulin Resistance, Coagulation Disorder
- Keywords
- Psoriasis, Endothelial dysfunction, Inflammation, Insulin resistance, Biologic therapy
- Medical subject headings
- Psoriasis, Inflammation, Insulin Resistance, Hemostatic Disorders, Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Arterial function - endothelial function
Endothelial function (flow-mediated dilation)
Measured: through study completion, an average of 6 months
Arterial function - arterial stiffness
Arterial stiffness (pulse wave velocity)
Measured: 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))
Measured: through study completion, an average of 6 months
Secondary outcomes (10)
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))
Measured: 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)
Measured: through study completion, an average of 6 months
Metabolic disturbances - dyslipidemia
Parameters of (pre)metabolic syndrome (lipid panel)
Measured: through study completion, an average of 6 months
Metabolic disturbances
Parameters of (pre)metabolic syndrome (TyG (triglyceride-glucose index))
Measured: through study completion, an average of 6 months
Liver steatosis
Laboratory markers (aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Fib4 score (Fibrosis-4))
Measured: through study completion, an average of 6 months
Coagulation
Circulating markers of coagulation activation (D-dimer, fibrinogen)
Measured: through study completion, an average of 6 months
Activation of hemostasis
Hemostatic assay (overall hemostasis potential (OHP) assay)
Measured: through study completion, an average of 6 months
Activation of coagulation
Coagulation assay (overall coagulation potential (OCP) assay)
Measured: through study completion, an average of 6 months
Platelet activation (1)
Circulating markers of platelet activation (mean platelet volume (MPV)
Measured: through study completion, an average of 6 months
Platelet activation (2)
Circulating markers of platelet activation (P-selectin)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start3 Jan 2022
- Primary completion1 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Klara Merzel Šabović, University Medical Centre Ljubljana
- Investigators
- Eva Klara Merzel Sabovic, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957120
- Sponsor's protocol ID
- PICANTI
- Acronym
- PaS
- Status last verified
- Jul 2023
- First submitted
- 18 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study. Immunol Res. 2025 Jan 8;73(1):28. doi: 10.1007/s12026-024-09584-4.
PubMed 39775226Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Arterial function is preserved in successfully treated patients with psoriasis vulgaris. Sci Prog. 2024 Oct-Dec;107(4):368504241287893. doi: 10.1177/00368504241287893.
PubMed 39403781Merzel Sabovic EK, Kraner Sumenjak T, Janic M. Residual metabolic burden in young psoriasis patients successfully treated with biologics. Arch Dermatol Res. 2024 Sep 27;316(9):647. doi: 10.1007/s00403-024-03403-4.
PubMed 39331218
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT05957120
- Acronym / sponsor ID
- PaS / PICANTI
- Conditions
- Psoriasis, Inflammation, Endothelial Dysfunction, Metabolic Disturbance, Insulin Resistance, Coagulation Disorder
- Keywords
- Psoriasis, Endothelial dysfunction, Inflammation, Insulin resistance, Biologic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months
Key exclusion criteria (11 listed)
- any treatment besides treatment of psoriasis
- carotid disease
- heart failure
- atrial fibrillation
- diabetes type 1 or 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial function - endothelial function
Time frame: through study completion, an average of 6 months
Endothelial function (flow-mediated dilation)
Arterial function - arterial stiffness
Time frame: through study completion, an average of 6 months
Arterial stiffness (pulse wave velocity)
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))
10 secondary outcomes
Inflammation
Time frame: through study completion, an average of 6 months
Insulin resistance
Time frame: through study completion, an average of 6 months
Metabolic disturbances - dyslipidemia
Time frame: through study completion, an average of 6 months
Metabolic disturbances
Time frame: through study completion, an average of 6 months
Liver steatosis
Time frame: through study completion, an average of 6 months
Coagulation
Time frame: through study completion, an average of 6 months
Activation of hemostasis
Time frame: through study completion, an average of 6 months
Activation of coagulation
Time frame: through study completion, an average of 6 months
Platelet activation (1)
Time frame: through study completion, an average of 6 months
Platelet activation (2)
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 39775226Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study. Immunol Res. 2025 Jan 8;73(1):28. doi: 10.1007/s12026-024-09584-4.
- Derived from this study: PubMed 39403781Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Arterial function is preserved in successfully treated patients with psoriasis vulgaris. Sci Prog. 2024 Oct-Dec;107(4):368504241287893. doi: 10.1177/00368504241287893.
- Derived from this study: PubMed 39331218Merzel Sabovic EK, Kraner Sumenjak T, Janic M. Residual metabolic burden in young psoriasis patients successfully treated with biologics. Arch Dermatol Res. 2024 Sep 27;316(9):647. doi: 10.1007/s00403-024-03403-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Klara Merzel Sabovic, MD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Inflammation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial function - endothelial function (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957120, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.