NCT04827706

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19,978

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

13 years

First QC Date

March 8, 2021

Last Update Submit

March 31, 2021

Conditions

Keywords

cardiomyopathychildrenendomyocardial biopsyepidemiologyheart failurecardiac magnetic resonance

Outcome Measures

Primary Outcomes (8)

  • Characteristics of myocarditis in Poland

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

    10 years

  • Seasonal occurrence

    Seasonal occurrence rate of myocarditis regarding to gender and age

    10 years

  • In-hospital mortality

    Occurrence of all-cause death during initial hospitalization for myocarditis

    10 years

  • Long-term mortality

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

    10 years

  • Analysis of in-hospital course of patients with myocarditis.

    Hospitalization length

    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)

    10 years

  • Occurrence of recurrent myocarditis

    Occurrence of recurrent hospitalization for myocarditis

    10 years

  • Occurrence of heart failure

    Occurrence of heart failure hospitalization after diagnosis of myocarditis

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with first myocarditis hospitalization in Poland in observed time period.

You may qualify if:

  • first myocarditis hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Cardiology, Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

MyocarditisDeath, Sudden, CardiacCardiomyopathiesArrhythmias, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcin Grabowski, Professor

    Medical University of Warsaw

    STUDY CHAIR
  • Grzegorz Opolski, Professor

    Medical University of Warsaw

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 1, 2021

Study Start

January 1, 2009

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations