Study Results
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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ACTIVE_NOT_RECRUITING
21783 participants
OBSERVATIONAL
2021-01-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years and older.
3. Permanent residency in Tula city and Tula region.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital
UNKNOWN
National Medical Research Center for Therapy and Preventive Medicine
OTHER_GOV
Responsible Party
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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
State Healthcare Institution of the Tula Region Tula Regional Clinical Hospital
Tula, , Russia
Countries
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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
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
Other Identifiers
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01-10/22
Identifier Type: -
Identifier Source: org_study_id
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