An observational study in Chronic Non-communicable Diseases, Cardiovascular Diseases and COVID-19, sponsored by National Medical Research Center for Therapy and Preventive Medicine. Active, not recruiting at 2 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by National Medical Research Center for Therapy and Preventive Medicine · Observational
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.
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.
128 studies on the registry are indexed under Noncommunicable Diseases; 44 are open to participants now.
This study's enrollment of 21,783 is above the median of 1,748 across 43 observational studies indexed under Noncommunicable Diseases.
Browse Noncommunicable Diseases studies →National Medical Research Center for Therapy and Preventive Medicine is the lead sponsor of 29 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
1. Permanent residency outside of Tula city and Tula region.
All-cause mortality
Time frame: 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
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
Proportion of patients with nonfatal myocardial infarction
Time frame: 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
Proportion of patients with cases of COVID-19 during follow-up
Time frame: 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
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
Plan to share: Undecided
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Medical Research Center for Therapy and Preventive Medicine