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Enrolling by invitation NCT06652399

Cardiovascular Imaging in Pediatric Myocarditis

— Observational Myocarditis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myocarditis. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Cohort Study: to Assess the Value of Cardiovascular Imaging in Pediatric Myocarditis

Overview

This study aims to utilize cardiac magnetic resonance (CMR) to assist in the clinical diagnosis, conduct consecutive assessments for myocardial tissue in pediatrics with myocarditis, and explore effective predictive factors for adverse outcomes in pediatric myocarditis. Participants will undergo baseline collection, laboratory tests, echocardiography, and CMR. All the consecutive data will be used to analyze the association with the diagnosis and prognosis of pediatric myocarditis.

Primary outcome measures

  • Adverse cardiovascular events [Time frame: 10 years after the onset]
Secondary outcome measures (1)
  • Secondary cardiovascular adverse events [Time frame: 10 years after the onset]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed or suspected pediatric myocarditis based on Diagnostic Recommendation for Myocarditis in Children (version 2018).
  • Age between 1 to 18 years old.

Exclusion criteria

  • Previous history of cardiovascular disease ( e.g. congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ).
  • MRI examination contraindications ;
  • Gadolinium contrast agent contraindications ;
  • CT examination contraindications ;
  • Comparison of iodine content.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Second University Hospital, Sichuan University — Chengdu

Publications

  • Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072. PMID 30545455
  • Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnos PMID 23824828
  • Kantor PF, Lougheed J, Dancea A, McGillion M, Barbosa N, Chan C, Dillenburg R, Atallah J, Buchholz H, Chant-Gambacort C, Conway J, Gardin L, George K, Greenway S, Human DG, Jeewa A, Price JF, Ross RD, Roche SL, Ryerson L, Soni R, Wilson J, Wong K; Children's Heart Failure Study Group. Presentation, diagnosis, and medical management of heart failure in children: Canadian Cardiovascular Society guid PMID 24267800
  • JCS Joint Working Group. Guidelines for diagnosis and treatment of myocarditis (JCS 2009): digest version. Circ J. 2011;75(3):734-43. doi: 10.1253/circj.cj-88-0008. Epub 2011 Feb 4. No abstract available. PMID 21304213
  • Howlett JG, McKelvie RS, Arnold JM, Costigan J, Dorian P, Ducharme A, Estrella-Holder E, Ezekowitz JA, Giannetti N, Haddad H, Heckman GA, Herd AM, Isaac D, Jong P, Kouz S, Liu P, Mann E, Moe GW, Tsuyuki RT, Ross HJ, White M; Canadian Cardiovascular Society. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure, update 2009: diagnosis and management of right-sided heart f PMID 19214293

Identifiers

NCT: NCT06652399 · WestChinaSUH2023094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗