RegiStry Of the multiFaceted medIcal cenTer

NCT ID: NCT06803862

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

21783 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Non-communicable Diseases Cardiovascular Diseases COVID-19 Multimorbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

UNKNOWN

Sponsor Role collaborator

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mikhail M Loukianov, MD, PhD

Role: STUDY_CHAIR

National Medical Research Center for Therapy and Preventive Medicine

Tatyana A Gomova, MD, PhD

Role: STUDY_CHAIR

State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Ruslan N Shepel, MD, PhD

Role: STUDY_CHAIR

National Medical Research Center for Therapy and Preventive Medicine

Oxana M Drapkina, MD, PhD, professor

Role: STUDY_CHAIR

National Medical Research Center for Therapy and Preventive Medicine

Locations

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National Research Center for Preventive Medicine of the Ministry of Health

Moscow, , Russia

Site Status

State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Tula, , Russia

Site Status

Countries

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Russia

References

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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

Reference Type RESULT

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

Reference Type RESULT

Other Identifiers

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01-10/22

Identifier Type: -

Identifier Source: org_study_id

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