Clinical trial NCT06652399: Cardiovascular Imaging in Pediatric Myocarditis
Official title: A Cohort Study: to Assess the Value of Cardiovascular Imaging in Pediatric Myocarditis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myocarditis
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From the past to April 2032, pediatric patients diagnosed or suspected myocarditis were recruited from West China Second University Hospital.

Brief summary: 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.


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.

Primary outcomes:
measure: Adverse cardiovascular events
timeFrame: 10 years after the onset
Secondary outcomes:
measure: Secondary cardiovascular adverse events
timeFrame: 10 years after the onset
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
References:
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citation: 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, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
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citation: 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.
citation: 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 failure, myocarditis, device therapy and recent important clinical trials. Can J Cardiol. 2009 Feb;25(2):85-105. doi: 10.1016/s0828-282x(09)70477-5.