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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04160533
Other study ID # 86
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 2023

Study information

Verified date September 2022
Source National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Contact Anna Aksenova, MD
Phone +74954146186
Email aksenovaannav@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The problem of the quality of primary health care medical system for patients with arterial hypertension is acute for the investigator's country, as these diseases are the most common and cause the high mortality of the population. The concept of "quality of primary health care medical system" includes its timeliness, accessibility and provision of medical care to the patient at the modern level, which is determined by the degree of performance by doctors of medical and diagnostic measures corresponding current clinical recommendations. The system of cardiovascular desease registries, established in the Federal State Clinical Hospital of the Russian Federation Ministry of Public Health with the automated analysis of data on examination and treatment, in comparison with clinical Recommendations. It makes possibility to identify shortcomings and develop approaches to improving the provision of medical care to patients in real clinical practice. Comparative analysis of the quality of examination and treatment in different samples of patients with cardiovascular desease, observed in 2018-2020, compared with results of previous years will identify ptrends in the provision of medical care to patients with cardiovascular desease.


Description:

The study will be conducted using the arterial hypertension registry method, which is a computer program with remote access that allows online collection medical data from medical primary care system. To minimize operator errors, doctors was trained before the work with the arterial hypertension registry. User's guide was developed and the rights of users was determined. Data of examination and treatment of patients from 18 years and older with an established diagnosis of hypertension will be added from outpatient cards into the registry of the arterial hypertension. The information is received by the Institution in an impersonal form through a certified dedicated security channel. Patients sign an informed consent for entering their medical data into the registry of arterial hypertension


Recruitment information / eligibility

Status Recruiting
Enrollment 10400
Est. completion date December 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: The diagnosis of arterial hypertension - Exclusion Criteria: No diagnosis of arterial hypertension -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Russian Federation Regional state budgetary institution of health care Altai Regional Cardiology Dispensary State budgetary institution of public health "Volgograd regional clinical hospital No. 1" clinic State budgetary health institution of the Kemerovo region "Kemerovo R Barnaul Altai
Russian Federation State Healthcare Institution "Engels City Polyclinic No. 2 Engels
Russian Federation State Healthcare Institution "Engels City Polyclinic No. 4 Engels
Russian Federation State budgetary health institution of the Kemerovo region "Kemerovo Regional Clinical Cardiology Dispensary named after Academician L.S. Barbarash Kemerovo
Russian Federation State budgetary institution of the ryazan region "regional clinical cardiological dispensary" Ryazan
Russian Federation Municipal budgetary institution of public health "City polyclinic ?1" Taganrog Branch ?1 Taganrog
Russian Federation Municipal budgetary institution of public health "City polyclinic ?1" Taganrog Branch ?2 Taganrog
Russian Federation Municipal budgetary institution of public health "City polyclinic ?1" Taganrog Branch ?3 Taganrog
Russian Federation Municipal budgetary institution of public health "City polyclinic ?1" Taganrog Branch ?4 Taganrog
Russian Federation Municipal budgetary institution of public health "City polyclinic ?2" Taganrog Branch ?1 Taganrog
Russian Federation Municipal budgetary institution of public health "City polyclinic ?2" Taganrog Branch ?4 Taganrog
Russian Federation Municipal budgetary institution of public health services "City ambulance hospital" city of Taganrog Taganrog
Russian Federation State Autonomous Healthcare Institution of the Tyumen Region "Tyumen Institute of Therapy Tyumen
Russian Federation Municipal Health Institution "City Hospital No. 1" Volgodonsk Volgodonsk
Russian Federation Municipal health institution "City polyclinic ?1" Volgodonsk Volgodonsk
Russian Federation Municipal health institution "City polyclinic ?3" Volgodonsk Volgodonsk
Russian Federation State budgetary institution of public health "Volgograd regional clinical hospital No. 1" clinic Volgograd

Sponsors (1)

Lead Sponsor Collaborator
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with blood pressure <140/90 mm Hg The level of systolic and diastolic blood pressure measured according to the rules described in the clinical guidelines for the treatment and diagnosis of arterial hypertension of the European Society of Cardiology during the visit (mmHg) is entered into the database by doctors. 2018 - 2021 years
Secondary Number of patients with a history of myocardial infarction, chronic renal desease, chronic heart failure, atrial fibrillation. Diagnosis data is entered by doctors as a "yes" or "no" category. 2018-2021
Secondary Antihypertensive medications Antihypertensive drugs the patient takes are entered into the database. Drugs are analyzed by groups and daily dosages 2018-2021
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