Clinical Trials Directory

Trials / Completed

CompletedNCT05189847

Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis

Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries

Status
Completed
Phase
Study type
Observational
Enrollment
3,059 (actual)
Sponsor
Eurasian Association of Therapists · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries

Detailed description

Information on demographics, comorbidities, methods for diagnosing multifocal atherosclerosis (MFA), prescribed therapy, and outcomes will be identified via medical records analysis. Results of arterial bed ultrasound examination (US), results of ankle-brachial index (ABI) measurements, along with clinical and anamnestic data on target organ damage in the MFA-affected areas will be used as the main source verifying the presence MFA. The follow-up period for each patient will span from the date of inclusion and over the next year with an additional 6 and 12 months of follow-up. Patients eligible for entry in the Register must be included and their details must be documented. The procedure for obtaining informed consent for the examination and collection of data must comply with the requirements of local legislation. Patients will be required to sign an informed consent document if required. Standardized electronic CRFs will be used in all research centers. The electronic data collection (EDC) system must be validated in accordance with current standards and legal requirements. Researchers will log into this system using individually assigned usernames and passwords. Data can only be entered and corrected by the researcher or other authorized personnel of the research center.

Conditions

Timeline

Start date
2022-02-01
Primary completion
2024-01-31
Completion
2024-01-31
First posted
2022-01-13
Last updated
2024-06-26

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT05189847. Inclusion in this directory is not an endorsement.