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Diagnosis of Structural Heart Disease Using MCG

Accurate Identification of Structural Heart Disease Using Magnetocardiography as an Innovative and Non-invasive Tool

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06315998
Enrollment
2914
Registered
2024-03-18
Start date
2024-03-18
Completion date
2025-09-30
Last updated
2024-08-21

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

Conditions

Structural Heart Abnormality

Brief summary

The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard.

Interventions

Magnetocardiography

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Those with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance. Structural heart disease includes cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.), congenital heart disease (including ventricular septal defect, atrial septal defect, patent ductus arteriosus, Tetralogy of Fallot) syndrome, tricuspid valve malformation, etc.), valvular heart disease (aortic valve stenosis, mitral valve stenosis, etc.), ventricular remodeling caused by myocardial ischemia or cardiac structural changes. * Signed the consent form.

Exclusion criteria

* Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal; * Those who are thought to be incapable of completing the relevant examinations by an attending physicians (or physicians with higher qualifications) due to unstable clinical conditions, metal implants, etc., or those who are unable to perform the examinations; * Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply; * Those with malignant tumors; * Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of the MCG in identifying structural heart diseasefrom the date of enrollment until the date of discharge, up to 30 daysUsing echocardiography or cardiac magnetic resonance as reference standard to assess the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and ROC of the cardiac magnetic image algorithm model for identification and localization of structural heart disease.

Countries

China

Contacts

Primary ContactJiaojiao Pang
jiaojiaopang@126.com0086-0531-82165398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026