PsoriasisNCT05200598
Cardiovascular Risk Predictors in Patients With Psoriasis
An observational study of Psoriasis and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Cardiovascular Diseases
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2021to 1 Sep 2024
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Considering the different severity of psoriasis, it is possible to divide patients with psoriasis into several subgroups: patients with mild psoriasis; patients with moderate psoriasis; patients with severe psoriasis who are not receiving systemic therapy; patients with severe psoriasis receiving systemic therapy with genetic-engineering biological drugs; patients with psoriatic arthritis receiving genetic-engineering biological drugs.
Who may be able to join
- Age over 18 years
- Written informed consent of the patient to participate in the study
Who cannot join
- Age under 18
- Pregnancy, lactation
- Very high cardiovascular risk
- Life-threatening, independently influencing prognosis and disabling diseases,
- Mental disorders that do not allow to give informed consent or answer questions adequately
- Refuse of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. The traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. As it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.
- Conditions
- Psoriasis, Cardiovascular Diseases
- Keywords
- psoriasis, cardiovascular risk, risk factors
- Medical subject headings
- Psoriasis, Cardiovascular Diseases
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 |
|---|---|---|
| Mild psoriasis | Not described | |
| Moderate psoriasis | Not described | |
| Severe psoriasis | Not described | |
| Patients without psoriasis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person)
Increased cardiovascular risk over the follow-up period (from low to very high)
Measured: 1 year
Secondary outcomes (5)
Overall mortality
Number of deaths due to all reasons
Measured: 1 year
Cardiovascular mortality
Number of deaths due to cardiovascular reasons
Measured: 1 year
Progression of psoriasis (PASI)
Progression of severity of psoriasis according to PASI (The Psoriasis Area and Severity Index - 0 to 4, none to very severe) score
Measured: 1 year
Quality of life (DLQI score)
Impact on quality of life by DLQI (Dermatology Life Quality Index - 0 to 30, no to extremely large impact) score
Measured: 1 year
Hospitalization due to cardiovascular reasons
Number of patients hospitalized due to cardiovascular reasons
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Mironova, I.M. Sechenov First Moscow State Medical University
- Investigators
- Olga Mironova, MD, PhD, Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200598
- Sponsor's protocol ID
- 22-21
- Status last verified
- Oct 2024
- First submitted
- 1 Jan 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Predictors in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT05200598
- Acronym / sponsor ID
- 22-21
- Conditions
- Psoriasis, Cardiovascular Diseases
- Keywords
- psoriasis, cardiovascular risk, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 21 Jan 2022 (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.
The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. The traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. As it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild psoriasis | – | – |
| Moderate psoriasis | – | – |
| Severe psoriasis | – | – |
| Patients without psoriasis | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Considering the different severity of psoriasis, it is possible to divide patients with psoriasis into several subgroups: patients with mild psoriasis; patients with moderate psoriasis; patients with severe psoriasis who are not receiving systemic therapy; patients with severe psoriasis receiving systemic therapy with genetic-engineering biological drugs; patients with psoriatic arthritis receiving genetic-engineering biological drugs.
Key inclusion criteria (2 listed)
- Age over 18 years
- Written informed consent of the patient to participate in the study
Key exclusion criteria (6 listed)
- Age under 18
- Pregnancy, lactation
- Very high cardiovascular risk
- Life-threatening, independently influencing prognosis and disabling diseases,
- Mental disorders that do not allow to give informed consent or answer questions adequately
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
SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person)
Time frame: 1 year
Increased cardiovascular risk over the follow-up period (from low to very high)
5 secondary outcomes
Overall mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 1 year
Progression of psoriasis (PASI)
Time frame: 1 year
Quality of life (DLQI score)
Time frame: 1 year
Hospitalization due to cardiovascular reasons
Time frame: 1 year
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 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Olga Mironova, MD, PhD principal investigator
Sechenov University
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 Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 2 inclusion and 6 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 8 Oct 2024. 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 Russia. 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?
SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.