Cardiovascular Imaging in Pediatric Myocarditis

NCT06652399 | Enrolling By Invitation

• 1 other identifier: WestChinaSUH2023094
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis

Outcome Measures

Primary Outcomes (1)

• Adverse cardiovascular events

  including all-cause death, orthotopic heart transplantation(HTx), malignant arrhythmia, readmission due to heart failure, progression to DCM.

  10 years after the onset

Secondary Outcomes (1)

• Secondary cardiovascular adverse events

  10 years after the onset

Study Arms (1)

Patients with pediatric myocarditis

Patients diagnosisd or suspected myocarditis based on the Diagnostic Recommendation for Myocarditis in Children (version 2018).

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 23824828 BACKGROUND

• 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 guidelines. Can J Cardiol. 2013 Dec;29(12):1535-52. doi: 10.1016/j.cjca.2013.08.008.

  PMID: 24267800 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19214293 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

the whole-blood sample will be collected for laboratory tests.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): April 1, 2033
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)