MyocarditisMYO-PLNCT04827706
Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis
An observational study of Myocarditis and Sudden Cardiac Death, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis, Sudden Cardiac Death, Cardiomyopathies
- How many people
- 19,978 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2009to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with first myocarditis hospitalization in Poland in observed time period.
Who may be able to join
- first myocarditis hospitalization
Who cannot join
- no specific exclusion criteria were applied
Trial locations and contacts
1 site in 1 country.
Poland1 site
First Department of Cardiology, Medical University of Warsaw
Warsaw, 02-097
About this study
Official title: Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis - Ten-year Perspectives From the MYO-PL Nationwide Database
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.
Read the 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.
- Conditions
- Myocarditis, Sudden Cardiac Death, Cardiomyopathies, Arrythmia, Heart Failure
- Keywords
- cardiomyopathy, children, endomyocardial biopsy, epidemiology, heart failure, cardiac magnetic resonance
- Medical subject headings
- Myocarditis, Death, Sudden, Cardiac, Cardiomyopathies, Arrhythmias, Cardiac, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of myocarditis in Poland
Distribution of myocarditis incidence regarding to voivodeship/ district, city size (number of residents), hospital and ward type of admission
Measured: 10 years
Seasonal occurrence
Seasonal occurrence rate of myocarditis regarding to gender and age
Measured: 10 years
In-hospital mortality
Occurrence of all-cause death during initial hospitalization for myocarditis
Measured: 10 years
Long-term mortality
Occurrence of all-cause death at 10-year observation.
Measured: 10 years
Analysis of in-hospital course of patients with myocarditis.
Hospitalization length
Measured: 10 years
Trends in the utilisation rate of diagnostic procedures.
Trends in the application rate of diagnostic procedures aimed at diagnosing myocarditis (i.e. cardiac magnetic resonance, endomyocardial biopsy, troponin, echocardiography, coronary angiography)
Measured: 10 years
Occurrence of recurrent myocarditis
Occurrence of recurrent hospitalization for myocarditis
Measured: 10 years
Occurrence of heart failure
Occurrence of heart failure hospitalization after diagnosis of myocarditis
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2009
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19,978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcin Grabowski, Professor, Study chair, Medical University of WarsawGrzegorz Opolski, Professor, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827706
- Sponsor's protocol ID
- MYO-PL
- Acronym
- MYO-PL
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data can be provided upon request
Publications
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.
PubMed 35084153Ozieranski 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.
PubMed 34682794
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis - Ten-year Perspectives From the MYO-PL Nationwide Database
- ClinicalTrials.gov ID
- NCT04827706
- Acronym / sponsor ID
- MYO-PL / MYO-PL
- Conditions
- Myocarditis, Sudden Cardiac Death, Cardiomyopathies, Arrythmia, Heart Failure
- Keywords
- cardiomyopathy, children, endomyocardial biopsy, epidemiology, heart failure, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19,978 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with first myocarditis hospitalization in Poland in observed time period.
Key inclusion criteria (1 listed)
- first myocarditis hospitalization
Key exclusion criteria (1 listed)
- no specific exclusion criteria were applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of myocarditis in Poland
Time frame: 10 years
Distribution of myocarditis incidence regarding to voivodeship/ district, city size (number of residents), hospital and ward type of admission
Seasonal occurrence
Time frame: 10 years
Seasonal occurrence rate of myocarditis regarding to gender and age
In-hospital mortality
Time frame: 10 years
Occurrence of all-cause death during initial hospitalization for myocarditis
Long-term mortality
Time frame: 10 years
Occurrence of all-cause death at 10-year observation.
Analysis of in-hospital course of patients with myocarditis.
Time frame: 10 years
Hospitalization length
Trends in the utilisation rate of diagnostic procedures.
Time frame: 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)
Occurrence of recurrent myocarditis
Time frame: 10 years
Occurrence of recurrent hospitalization for myocarditis
Occurrence of heart failure
Time frame: 10 years
Occurrence of heart failure hospitalization after diagnosis of myocarditis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 35084153Ozieranski 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.
- Derived from this study: PubMed 34682794Ozieranski 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.
- Individual participant dataSharing planned: Undecided. data can be provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Grabowski, Professor study chair
Medical University of Warsaw
Grzegorz Opolski, Professor study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Sudden Cardiac Death, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of myocarditis in Poland (time frame: 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.