Clinical trial NCT04827706: Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis
Official title: Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis - Ten-year Perspectives From the MYO-PL Nationwide Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocarditis
Sudden Cardiac Death
Cardiomyopathies
Arrythmia
Heart Failure
Keywords: cardiomyopathy
children
endomyocardial biopsy
epidemiology
heart failure
cardiac magnetic resonance
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 19978
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with first myocarditis hospitalization in Poland in observed time period.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* first myocarditis hospitalization

Exclusion Criteria:

* no specific exclusion criteria were applied

Primary outcomes:
measure: Characteristics of myocarditis in Poland
timeFrame: 10 years
measure: Seasonal occurrence
timeFrame: 10 years
measure: In-hospital mortality
timeFrame: 10 years
measure: Long-term mortality
timeFrame: 10 years
measure: Analysis of in-hospital course of patients with myocarditis.
timeFrame: 10 years
measure: Trends in the utilisation rate of diagnostic procedures.
timeFrame: 10 years
measure: Occurrence of recurrent myocarditis
timeFrame: 10 years
measure: Occurrence of heart failure
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: First Department of Cardiology, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Grabowski, Professor
role: STUDY_CHAIR
affiliation: Medical University of Warsaw
name: Grzegorz Opolski, Professor
role: STUDY_CHAIR
References:
citation: Ozieranski K, Tyminska A, Chabior A, Kruk M, Kon B, Maciejewski C, Opolski G, Grabowski M. Sex differences in incidence, management, and outcomes in adult patients aged over 20 years with clinically diagnosed myocarditis in the last 10 years: data from the MYO-PL nationwide database. Pol Arch Intern Med. 2022 Apr 28;132(4):16199. doi: 10.20452/pamw.16199. Epub 2022 Jan 27.
citation: Ozieranski K, Tyminska A, Kruk M, Kon B, Skwarek A, Opolski G, Grabowski M. Occurrence, Trends, Management and Outcomes of Patients Hospitalized with Clinically Suspected Myocarditis-Ten-Year Perspectives from the MYO-PL Nationwide Database. J Clin Med. 2021 Oct 12;10(20):4672. doi: 10.3390/jcm10204672.