Clinical trial NCT06641830: A Integrated Study in Pediatric Patients with Cardiomyopathy
Official title: A Pediatric Cardiomyopathy Cohort Study: the Emerging Role of CMR in Clinical Practice
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pediatric Cardiomyopathy
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 800
Sex: ALL
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 Jaunary 2034, pediatric patients diagnosed with cardiomyopathy were recruited from West China Second University Hospital.

Brief summary: This observational study aims to manage children with cardiomyopathy in the long term. It collects baseline data, laboratory test data, and medical imaging data during the hospitalization and follow-up.

During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and when hospitalization and follow-up, and the baseline data will be collected in the admission. All the above examination data will be analysed to assess the clinical characteristics, current status of diagnosis and treatment, and the prognostic risk factors for children with cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients diagnosed with cardiomyopathy.

Exclusion Criteria:

* a history of cardiovascular disease ( such as congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ).
* Mentally abnormal.
* Poor compliance.
* Heart, kidney and other important organs were seriously incomplete.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 10 years after the onset
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
References:
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citation: Lipshultz SE, Law YM, Asante-Korang A, Austin ED, Dipchand AI, Everitt MD, Hsu DT, Lin KY, Price JF, Wilkinson JD, Colan SD. Cardiomyopathy in Children: Classification and Diagnosis: A Scientific Statement From the American Heart Association. Circulation. 2019 Jul 2;140(1):e9-e68. doi: 10.1161/CIR.0000000000000682. Epub 2019 May 28.
citation: Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.