RegiStry Of the multiFaceted medIcal cenTer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21,783
- 试验地点
- 4
- 主要终点
- All-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized to the Tula Regional Clinical Hospital from 01.01.2021 to 31.12.
- •Age 18 years and older.
- •Permanent residency in Tula city and Tula region.
排除标准
- •1. Permanent residency outside of Tula city and Tula region.
结局指标
主要结局
All-cause mortality
时间窗: 5 years after inclusion
Time to all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, coronary/carotid revascularization
时间窗: from discharge up to 5 years after reference hospitalization
次要结局
- 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)
- Hospitalization due to COVID-19, proportion of patients with hospitalization due to COVID-19(from discharge up to 5 years after reference hospitalization)