RegiStry Of the multiFaceted medIcal cenTer (SOFIT)

May 19, 2026 updated by: National Medical Research Center for Therapy and Preventive Medicine

This study is a prospective medical registry (the SOFIT Registry) that enrolls all patients hospitalized in various departments of the Tula Regional Clinical Hospital in 2021.

The primary objective of the study is to analyze demographic, clinical and anamnestic characteristics of patients, history of COVID-19, the structure of multimorbidity, the quality of diagnostics and treatment, as well as short-term and long-term outcomes. As a part of this project a five-year follow-up is planned. The information will be obtained from Medical Information System resource of the hospital and regional and federal electronic databases.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Nowadays in the Russian Federation chronic non-communicable diseases are one of the most common causes of hospitalization and also a concomitant pathology in the majority of patients undergoing hospital treatment in departments of various profiles. The creation of a prospective medical registry is an informative method for a comprehensive assessment of the characteristics of patients, including demographic, clinical and anamnestic data, the structure of multimorbidity, the quality of diagnostics and treatment as well as an assessment of short-term and long-term outcomes.

The aim of this project is to create a prospective registry of a multifaceted medical center (SOFIT), including all patients hospitalized in various departments of the hospital.

Patients admitted to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021 were retrospectively enrolled into this study. The information from electronic medical records was obtained using the Medical Information System resource of the hospital.

At the first stage, it is planned to analyze the age and gender characteristics of patients, the proportion of cases of cardiovascular and chronic non-cardiac diseases and their combinations, the frequency of a history of COVID-19, laboratory and instrumental data, cardiovascular pharmacotherapy prescribed in the hospital and hospital mortality. The obtained data will be compared in the cardiologic, therapeutic and other departments.

At the second stage, the prospective follow-up will be carried out up to 5 years after the reference hospitalization. It will involve the evaluation of long-term outcomes, such as all-cause mortality, cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral stroke, hospitalizations and surgical interventions for cardiovascular diseases), cases of COVID-19 based on patient's medical records. The information about cases of death (date and cause of death, place of death registration), cardiovascular events during follow-up will be obtained from the regional database of death cases in population of the Tula region and from other regional electronic databases. The information about cases of COVID-19 will be obtained from the Russian Federal Registry of COVID-19.

Study Type

Observational

Enrollment (Actual)

21783

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 101990
        • National Research Center for Preventive Medicine of the Ministry of Health
      • Tula, Russia, 300053
        • State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021 who meet inclusion criteria and don't have exclusion criteria will be included in this study.

Description

Inclusion Criteria:

  1. Patients hospitalized to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.2021.
  2. Age 18 years and older.
  3. Permanent residency in Tula city and Tula region.

Exclusion Criteria:

1. Permanent residency outside of Tula city and Tula region.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 5 years after inclusion
5 years after inclusion
Time to all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, coronary/carotid revascularization
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to composite endpoint (nonfatal myocardial infarction or nonfatal cerebral stroke or coronary/carotid revascularization)
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization
Proportion of patients with nonfatal myocardial infarction
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization
Proportion of patients with nonfatal cerebral stroke
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization
Proportion of patients with cases of COVID-19 during follow-up
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization
Hospitalization due to cardiovascular disease, proportion of patients with hospitalization due to cardiovascular disease
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization
Hospitalization due to COVID-19, proportion of patients with hospitalization due to COVID-19
Time Frame: from discharge up to 5 years after reference hospitalization
from discharge up to 5 years after reference hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Collaborators

State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Investigators

  • Study Chair: Mikhail M Loukianov, MD, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Tatyana A Gomova, MD, PhD, State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital
  • Study Chair: Ruslan N Shepel, MD, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Oxana M Drapkina, MD, PhD, professor, National Medical Research Center for Therapy and Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ignatieva VI, Kontsevaya AV, Lukyanov MM, et al. Cost-effectiveness analysis of increasing drug therapy coverage for patients with coronary artery disease in combination with atrial fibrillation and heart failure. Cardiovascular Therapy and Prevention. 2024;23(4):3950. (In Russ.) https://doi.org/10.15829/1728-8800-2024-3950
  • Loukianov MM, Gomova TA, Savishceva AA, et al. RegiStry Of the multiFaceted medIcal cenTer (SOFIT): the main tasks, development, and the first results. Russian Journal of Preventive Medicine. 2023;26(6):46 54. (In Russ.) https://doi.org/10.17116/profmed20232606146

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-10/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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