Myocarditis Registry for Children and Adolescents - MYKKE
NCT ID: NCT02590341
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1500 participants
OBSERVATIONAL
2014-06-30
2024-05-31
Brief Summary
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Detailed Description
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The treating physicians enter basic data from patients enrolled at the study site via an online web interface to a central study database. For each patient, a specific patient identification number (PID) is generated based on name, first name and date of birth in order to store data in a pseudonymized fashion. As the PIDs are generated by a specific algorithm, data from the same patient are always linked to the same dataset even when data from different visits are entered by different institutions.
The web interface provides two different forms for each patient. The first form ("general sheet") is filled-in only at first presentation and consists of 12 items regarding disease and patient history, and initial symptoms of the disease. The second type of sheet ("current visit") can be generated once for each new patient visit and includes 52 items on characteristics of the current visit, current symptoms, diagnostic tests performed, confidence of the treating physician in the diagnosis on a subjective scale, left-ventricular function, therapy, complications, and follow-up care provider after discharge. Items primarily require yes/no responses via ticking respective boxes, allowing for completing each data sheet in \<5 minutes when all data are available.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age \<18 years
* Written informed consent of the parents or legal guardians
Exclusion Criteria
17 Years
ALL
No
Sponsors
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Competence Network for Congenital Heart Defects
OTHER_GOV
German Heart Institute
OTHER
Responsible Party
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Principal Investigators
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Daniel R Messroghli, MD
Role: STUDY_DIRECTOR
German Heart Institute
Stephan N Schubert, MD
Role: STUDY_DIRECTOR
German Heart Institute
Locations
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Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Charite - Universitätsmedizin Berlin
Berlin, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Klinikum Links der Weser
Bremen, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, , Germany
Universitätsklinikum Giessen und Marburg
Giessen, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Universitäres Herzzentrum Hamburg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Countries
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Central Contacts
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Related Links
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Website of MYKKE registry (German language only)
Other Identifiers
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MYKKE Registry
Identifier Type: -
Identifier Source: org_study_id
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