Myocarditis Registry for Children and Adolescents - MYKKE

NCT ID: NCT02590341

Last Updated: 2015-10-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2024-05-31

Brief Summary

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MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.

Detailed Description

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MYKKE is a long-term prospective registry providing a core platform for clinical research studies, which can be attached in a modular fashion. After a six-month pilot phase including 8 centers, the basic registry was opened in June 2014 to all hospitals in Germany treating patients with paediatric heart disease. While the scientific lead is with two study coordinators and a study group consisting of principal investigators from the collaborating centres ("MYKKE Investigators"), MYKKE is hosted and technically administered by the Competence Network for Congenital Heart Defects, which was initiated in 2003 by the Federal Ministry of Education and Research of the German government and is now part of the German Center for Cardiovascular Research (DZHK). Ethical approval was first obtained at the initiating centre (Deutsches Herzzentrum Berlin) and subsequently confirmed by local authorities of all collaborating centres.

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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Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Admission or referral diagnosis of myocarditis
* Age \<18 years
* Written informed consent of the parents or legal guardians

Exclusion Criteria

* Unwillingness to give consent
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Competence Network for Congenital Heart Defects

OTHER_GOV

Sponsor Role collaborator

German Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Charite - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Deutsches Herzzentrum Berlin

Berlin, , Germany

Site Status RECRUITING

Klinikum Links der Weser

Bremen, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitätsklinikum Giessen und Marburg

Giessen, , Germany

Site Status RECRUITING

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status NOT_YET_RECRUITING

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum des Saarlandes

Homburg, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Pickardt, PhD

Role: CONTACT

+49 30 4593 ext. 7279

Manuela Bauer

Role: CONTACT

+49 30 4593 ext. 2879

Related Links

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http://mykke.de

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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