Cardiovascular Risk Predictors in Patients With Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05200598
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

I.M. Sechenov First Moscow State Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Olga Mironova, MD, PhD
Principal Investigator Affiliation Sechenov University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Cardiovascular Diseases
Arms & Interventions

Arms

: Mild psoriasis

: Moderate psoriasis

: Severe psoriasis not receiving systemic therapy

: Severe psoriasis receiving systemic therapy with genetic-engineering biological drugs

: Patients without psoriasis

Interventions

Contact a Trial Team

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International Sites

University Clinical Hospital #2, Moscow, Russian Federation

Status

Recruiting

Address

University Clinical Hospital #2

Moscow, , 119991

Site Contact

Olga Kuzmina, MD

oakuzzmina@gmail.com

+79260497300

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