Cardiovascular Risk Predictors in Patients With Psoriasis

NCT05200598 | Completed

• 1 other identifier: 22-21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person)

  Increased cardiovascular risk over the follow-up period (from low to very high)

  1 year

Secondary Outcomes (5)

• Overall mortality

  1 year

• Cardiovascular mortality

  1 year

• Progression of psoriasis (PASI)

  1 year

• Quality of life (DLQI score)

  1 year

• Hospitalization due to cardiovascular reasons

  1 year

Study Arms (4)

Mild psoriasis

Moderate psoriasis

Severe psoriasis

Patients without psoriasis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital #2

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olga Mironova, MD, PhD

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: January 21, 2022
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

RU (1)