Diagnosis of Structural Heart Disease Using MCG

Structural Heart Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315998
• Other study ID #: MCG-Structural
• Status: Not yet recruiting
• Start date: March 18, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang
• Phone: 0086-0531-82165398
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2914
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Structural Heart Abnormality

Intervention

Device:
• Magnetocardiography
Magnetocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of the MCG in identifying structural heart disease	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.	from the date of enrollment until the date of discharge, up to 30 days