The COVID-RASi Trial (COVID-19)
NCT04591210
COVID-19, Cardiovascular Diseases
Maceió, Alagoas, Brazil
View Trial DetailsNCT Number: NCT06803862
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
National Research Center for Preventive Medicine of the Ministry of Health, Moscow, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 years after inclusion
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
Time frame: from discharge up to 5 years after reference hospitalization
National Medical Research Center for Therapy and Preventive Medicine
Other Gov
Acronym: SOFIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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