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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200598
Other study ID # 22-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date September 1, 2024

Study information

Verified date November 2023
Source I.M. Sechenov First Moscow State Medical University
Contact Olga Kuzmina, MD
Phone +79260497300
Email oakuzzmina@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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 information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Russian Federation University Clinical Hospital #2 Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall mortality Number of deaths due to all reasons 1 year
Secondary Cardiovascular mortality Number of deaths due to cardiovascular reasons 1 year
Secondary 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 1 year
Secondary 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 1 year
Secondary Hospitalization due to cardiovascular reasons Number of patients hospitalized due to cardiovascular reasons 1 year
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