Cardiovascular Risk Predictors in Patients With Psoriasis

Completed

• Conditions: Psoriasis; Cardiovascular Diseases

• Registration Number: NCT05200598
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2022-01-01
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-21
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall mortality	1 year	Number of deaths due to all reasons
Cardiovascular mortality	1 year	Number of deaths due to cardiovascular reasons
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
Hospitalization due to cardiovascular reasons	1 year	Number of patients hospitalized due to cardiovascular reasons
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

Trial Locations

Locations (1)

University Clinical Hospital #2; 🇷🇺 Moscow, Russian Federation