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Automatic View Recognition, Measurement and Establishment of Normal Value System for the Seven - step Ultrasonic Screening Method of Congenital Heart Disease in Children

Automatic View Recognition, Measurement and Establishment of Normal Value System for the Seven - step Ultrasonic Screening Method of Congenital Heart Disease in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120147
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Gold Standard:The echocardiographic diagnostic results of senior cardiac ultrasound specialists
Index test:Cardiac Ultrasound

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 0 days to 18 years old (subject to ID card or birth certificate); 2. Ethnicity: Chinese children; 3. Normal clinical evaluation: no cyanosis, clubbing fingers/toes were found in physical examination; No pathological heart murmur was detected by auscultation. Blood pressure was within the normal range of people of the same age, sex and height. 4. Ecg was normal: sinus rhythm, no conduction block or ectopic rhythm; 5. Normal echocardiography: the "seven-step method" of echocardiography confirmed that the heart segment analysis was normal, the heart structure and large vessel connection were normal, and the ventricular wall motion was normal. 6. Informed consent: The legal guardians of the children knew the purpose of this study, voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of acquired heart disease: Individuals with a history of Kawasaki disease, rheumatic heart disease, myocarditis, cardiomyopathy, infective endocarditis, or other similar conditions; 2.Systemic diseases affecting the heart: Patients with diseases that may affect cardiac morphology or function, such as severe anemia, hyperthyroidism/hypothyroidism, hypertension, renal diseases, or connective tissue diseases; 3.Genetic and chromosomal abnormalities: Those diagnosed with Down syndrome, Marfan syndrome, or other known syndromes associated with cardiovascular abnormalities; 4.Thoracic deformities: Presence of pectus excavatum, pectus carinatum, or severe scoliosis that significantly impairs the acoustic window for ultrasound scanning; 5.Suboptimal image quality: Cases where clear standard views of the Seven-Step Approach or distinct measurement landmarks cannot be obtained due to poor acoustic window conditions caused by infant crying/agitation, extreme obesity, or other factors.

Design outcomes

Primary

MeasureTime frame
Error;Goodness of fit, R2;

Countries

China

Contacts

Public ContactYe Jingjing

Children's Hospital,Zhejiang University School of Medicine

yejj1180@163.com+86 571 86670532

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026