RegiStry Of the multiFaceted medIcal cenTer

NCT06803862 | Active Not Recruiting DMC

• 1 other identifier: 01-10/22
• Study Type: observational
• Target: 21,783
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Non-communicable Diseases; Cardiovascular Diseases; COVID-19; Multimorbidity

Keywords

hospital registry; multifaceted medical center; cardiovascular diseases; multimorbidity; chronic non-communicable diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. Permanent residency outside of Tula city and Tula region.

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead
• State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital: collaborator

Study Sites (2)

National Research Center for Preventive Medicine of the Ministry of Health

Moscow, 101990, Russia

Location

State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital

Tula, 300053, Russia

Location

Related Publications (2)

• 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

  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

  RESULT

MeSH Terms

Conditions

Noncommunicable Diseases; Cardiovascular Diseases; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

RU (2)