Diagnosis of Structural Heart Disease Using MCG

NCT06315998 | Recruiting

• 1 other identifier: MCG-Structural
• Study Type: observational
• Target: 2,914
• Locations: 1 country
• Sites: 1

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.

Conditions

Structural Heart Abnormality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Training and testing cohort

Device: Magnetocardiography

External validation cohort

Device: Magnetocardiography

Interventions

Magnetocardiography DEVICE

Magnetocardiography

External validation cohort; Training and testing cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

China, Shandong Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Magnetocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Yuguo Chen, Professor

  Qliu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang

CONTACT

0086-0531-82165398; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 18, 2024
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-02

Locations

CN (1)