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临床试验/NCT04827706
NCT04827706Unknown不适用

Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis - Ten-year Perspectives From the MYO-PL Nationwide Database

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 19,978 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
19,978
试验地点
1
主要终点
Seasonal occurrence

研究概览

简要总结

The epidemiology of myocarditis is largely unknown and based mainly on small single-center studies. The study aim to evaluate the current incidence, clinical characteristics and outcomes of patients hospitalized due to myocarditis in a general population.

详细描述

In this retrospective-prospective study, data from the National Health Fund (NHF), which is the only public healthcare insurer in Poland is used. The NHF reimburses drugs and healthcare services provided by healthcare providers (both public and private) with public funds collected from health insurance premiums. In Poland, public health insurance is obligatory for almost all Poles - in December 2019, 88.4% of approx. 38 million Poles had public health insurance and were entitled to obtain healthcare services and drugs reimbursed by the NHF.

Based on NHF claims data, the healthcare services reported over the years 2009-2021 with a diagnosis of myocarditis - hospitalizations reported with codes I40, I40.0, I40.1, I40.8, I40.9, I41, I41.0, I41.1, I41.2, I41.8, I51.4, B33.2 are derived according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). The dataset is narrowed to the first myocarditis hospitalization, i.e. patients for whom no information about the diagnosis of myocarditis is reported in the 400 days preceding the hospitalization. For such a group of patients, and to establish the baseline characteristics of the patients, data is analyzed 400 days back from the initial diagnosis of myocarditis. Also, in-hospital and long-term outcomes are analyzed, including all-cause mortality as well as the occurrence of selected diseases (defined as receiving a service where selected ICD-10 was reported), and selected procedures are obtained, defined with codes according to International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). For the follow-up, at least a six-month period is required.

To show differences related to the age of patients hospitalized due to myocarditis, baseline characteristics and long-term outcomes are assessed with regard to age groups.

Data from the Central Statistical Office of Poland is also used to refer the obtained results to the population of Poland and to obtain life tables for survival analysis.

No specific exclusion criteria were applied. No ethics approval was required for this study, as it involved the analysis of administrative data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • first myocarditis hospitalization

排除标准

  • no specific exclusion criteria were applied

结局指标

主要结局

Seasonal occurrence

时间窗: 10 years

Seasonal occurrence rate of myocarditis regarding to gender and age

Long-term mortality

时间窗: 10 years

Occurrence of all-cause death at 10-year observation.

In-hospital mortality

时间窗: 10 years

Occurrence of all-cause death during initial hospitalization for myocarditis

Analysis of in-hospital course of patients with myocarditis.

时间窗: 10 years

Hospitalization length

Trends in the utilisation rate of diagnostic procedures.

时间窗: 10 years

Trends in the application rate of diagnostic procedures aimed at diagnosing myocarditis (i.e. cardiac magnetic resonance, endomyocardial biopsy, troponin, echocardiography, coronary angiography)

Characteristics of myocarditis in Poland

时间窗: 10 years

Distribution of myocarditis incidence regarding to voivodeship/ district, city size (number of residents), hospital and ward type of admission

Occurrence of heart failure

时间窗: 10 years

Occurrence of heart failure hospitalization after diagnosis of myocarditis

Occurrence of recurrent myocarditis

时间窗: 10 years

Occurrence of recurrent hospitalization for myocarditis

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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