Diagnosis of Structural Heart Disease Using MCG

Recruiting

• Conditions: Structural Heart Abnormality
• Interventions: Device: Magnetocardiography

• Registration Number: NCT06315998
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-12
• Study Start: 2024-03-18
• Study First Posted: 2024-03-18
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2914

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
External validation cohort	Magnetocardiography	-
Training and testing cohort	Magnetocardiography	-

Primary Outcome Measures

Name	Time	Method
The efficacy of the MCG in identifying structural heart disease	from the date of enrollment until the date of discharge, up to 30 days	Using 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.

Trial Locations

Locations (1)

China, Shandong Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China