Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06803862

RegiStry Of the multiFaceted medIcal cenTer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Research Center for Preventive Medicine of the Ministry of Health, Moscow, Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Permanent residency outside of Tula city and Tula region.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 5 years after inclusion

  2. 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

Secondary outcomes

  1. 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

  2. Proportion of patients with nonfatal myocardial infarction

    Time frame: from discharge up to 5 years after reference hospitalization

  3. Proportion of patients with nonfatal cerebral stroke

    Time frame: from discharge up to 5 years after reference hospitalization

  4. Proportion of patients with cases of COVID-19 during follow-up

    Time frame: from discharge up to 5 years after reference hospitalization

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Collaborators

  • State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Registry information

Acronym: SOFIT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.