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Cardiovascular Risk Predictors in Patients With Psoriasis

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05200598
Collaborator
(none)
200
Enrollment
1
Location
35
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular Risk Predictors in Patients With Psoriasis
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Mild psoriasis
    Moderate psoriasis
    Severe psoriasis not receiving systemic therapy
    Severe psoriasis receiving systemic therapy with genetic-engineering biological drugs
    Patients without psoriasis

    Outcome Measures

    Primary Outcome Measures

    1. SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person) [1 year]

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

    Secondary Outcome Measures

    1. Overall mortality [1 year]

      Number of deaths due to all reasons

    2. Cardiovascular mortality [1 year]

      Number of deaths due to cardiovascular reasons

    3. Progression of psoriasis (PASI) [1 year]

      Progression of severity of psoriasis according to PASI (The Psoriasis Area and Severity Index - 0 to 4, none to very severe) score

    4. Quality of life (DLQI score) [1 year]

      Impact on quality of life by DLQI (Dermatology Life Quality Index - 0 to 30, no to extremely large impact) score

    5. Hospitalization due to cardiovascular reasons [1 year]

      Number of patients hospitalized due to cardiovascular reasons

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Clinical Hospital #2 Moscow Russian Federation 119991

    Sponsors and Collaborators

    • I.M. Sechenov First Moscow State Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University
    ClinicalTrials.gov Identifier:
    NCT05200598
    Other Study ID Numbers:
    • 22-21
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Olga Mironova, Associate Professor, I.M. Sechenov First Moscow State Medical University
    psoriasis
    cardiovascular risk
    risk factors
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Psoriasis

    Study Results

    No Results Posted as of Apr 27, 2022