Cardiovascular Risk Predictors in Patients With Psoriasis

November 20, 2023 updated by: Olga Mironova, I.M. Sechenov First Moscow State Medical University
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Age over 18 years
  • Written informed consent of the patient to participate in the study

Exclusion Criteria:

  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Mild psoriasis
Moderate psoriasis
Severe psoriasis not receiving systemic therapy
Severe psoriasis receiving systemic therapy with genetic-engineering biological drugs
Patients without psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: 1 year
Number of deaths due to all reasons
1 year
Cardiovascular mortality
Time Frame: 1 year
Number of deaths due to cardiovascular reasons
1 year
Progression of psoriasis (PASI)
Time Frame: 1 year
Progression of severity of psoriasis according to PASI (The Psoriasis Area and Severity Index - 0 to 4, none to very severe) score
1 year
Quality of life (DLQI score)
Time Frame: 1 year
Impact on quality of life by DLQI (Dermatology Life Quality Index - 0 to 30, no to extremely large impact) score
1 year
Hospitalization due to cardiovascular reasons
Time Frame: 1 year
Number of patients hospitalized due to cardiovascular reasons
1 year

Collaborators and Investigators

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

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Olga Mironova, MD, PhD, Sechenov University

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)

October 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 1, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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