Diagnosis of Structural Heart Disease Using MCG

March 12, 2024 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2914

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training and testing cohort
Device: Magnetocardiography
Magnetocardiography
External validation cohort
Device: Magnetocardiography
Magnetocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of the MCG in identifying structural heart disease
Time Frame: 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.
from the date of enrollment until the date of discharge, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Yuguo Chen, Professor, Qliu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 18, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCG-Structural

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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