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Enrolling by Invitation

NCT Number: NCT06652399

Cardiovascular Imaging in Pediatric Myocarditis

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.

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adverse cardiovascular events

    Time frame: 10 years after the onset

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

Secondary outcomes

  1. Secondary cardiovascular adverse events

    Time frame: 10 years after the onset

    including mild reduction of cardiac function, persistent mild AVB and other arrhythmias, left chest tightness, palpitations and other clinical symptoms.

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2032
Study completion
2033
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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