Cardiovascular Risk Predictors in Patients With Psoriasis

Cardiovascular Diseases Clinical Trial

Official title:

Cardiovascular Risk Predictors in Patients With Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200598
• Other study ID #: 22-21
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Psoriasis

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