MYO-PL: Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis

Sponsor
Medical University of Warsaw (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04827706
Collaborator
(none)
19,978
Enrollment
1
Location
156
Anticipated Duration (Months)
128.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    19978 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis - Ten-year Perspectives From the MYO-PL Nationwide Database
    Actual Study Start Date :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Characteristics of myocarditis in Poland [10 years]

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

    2. Seasonal occurrence [10 years]

      Seasonal occurrence rate of myocarditis regarding to gender and age

    3. In-hospital mortality [10 years]

      Occurrence of all-cause death during initial hospitalization for myocarditis

    4. Long-term mortality [10 years]

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

    5. Analysis of in-hospital course of patients with myocarditis. [10 years]

      Hospitalization length

    6. Trends in the utilisation rate of diagnostic procedures. [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)

    7. Occurrence of recurrent myocarditis [10 years]

      Occurrence of recurrent hospitalization for myocarditis

    8. Occurrence of heart failure [10 years]

      Occurrence of heart failure hospitalization after diagnosis of myocarditis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • first myocarditis hospitalization
    Exclusion Criteria:
    • no specific exclusion criteria were applied

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1First Department of Cardiology, Medical University of WarsawWarsawPoland02-097

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

    • Study Chair: Marcin Grabowski, Professor, Medical University of Warsaw
    • Study Chair: Grzegorz Opolski, Professor, Medical University of Warsaw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT04827706
    Other Study ID Numbers:
    • MYO-PL
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Warsaw
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2021