RegiStry Of the multiFaceted medIcal cenTer

Active, not recruiting

• Conditions: Chronic Non-communicable Diseases; Cardiovascular Diseases; COVID-19; Multimorbidity

• Registration Number: NCT06803862
• Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2021-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21783

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

National Research Center for Preventive Medicine of the Ministry of Health; 🇷🇺 Moscow, Russian Federation

State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital; 🇷🇺 Tula, Russian Federation