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Clinical Trials/NCT06652399
NCT06652399
Enrolling By Invitation
Not Applicable

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

West China Second University Hospital1 site in 1 country100 target enrollmentNovember 1, 2023
ConditionsMyocarditis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocarditis
Sponsor
West China Second University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Adverse cardiovascular events
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
April 1, 2033
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
West China Second University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ling-Yi Wen

Principal Investigator

West China Second University Hospital

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.

Outcomes

Primary Outcomes

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

  • Secondary cardiovascular adverse events(10 years after the onset)

Study Sites (1)

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