MCG is Clinically Applied to Evaluate Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease

November 7, 2023 updated by: Nanhai Hospital, Guangdong Provincial People's Hospital

The Clinical Application of Magnetocardiography (MCG) as a Non-invasive Diagnostic Tool for Evaluating Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease

The objective of this observational study is to evaluate the diagnostic effectiveness of magnetocardiography (MCG) in patients with stable coronary artery disease (SCAD) and compare it with coronary CTA (CCTA). Additionally, the study aims to determine the most suitable diagnostic index for MCG. The primary question it seeks to address is whether MCG or MCG combined with CCTA can be utilized to guide the clinical application of percutaneous coronary intervention (PCI) for coronary heart disease.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. Patients aged≥18 years with stable coronary artery disease (CCTA stenosis 30%-90%) underwent sequential examinations of MCG and CCTA. The results of CCTA were assessed using CT-FFR, and the diagnostic effectiveness of MCG in evaluating myocardial ischemia was analyzed using CT-FFR as the reference standard. Simultaneously, MCG was compared to CCTA to determine the clinical value of MCG in the functional evaluation of myocardial ischemia.
  2. Coronary angiography was performed in patients who met the criteria for the procedure, and revascularization was carried out based on the intraoperative situation. Patients who underwent revascularization were followed up for 1 year, with major adverse cardiovascular events (MACE) as the endpoint. The clinical value of MCG in guiding the treatment of patients with SCAD was evaluated by reviewing the proportion of coronary angiography, revascularization, and MACE in the enrolled patients.

Study Type

Observational

Enrollment (Estimated)

291

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

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China
        • Recruiting
        • Nanhai Hospital, Guangdong Provincial People's Hospital
        • Contact:
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected stable coronary artery disease were enrolled in a consecutive group at Nanhai Hospital of Guangdong Provincial People's Hospital.

Description

Inclusion Criteria:

  1. Age ≥18 years old.
  2. Stable coronary artery disease patients with a coronary CTA stenosis degree of 30% to 90%.
  3. Sign informed consent.

Exclusion Criteria:

  1. Patients diagnosed with acute coronary syndrome.
  2. Patients diagnosed with hypertrophic cardiomyopathy.
  3. Patients diagnosed with dilated cardiomyopathy.
  4. Patients with complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, and complete bundle branch block.
  5. Patients with a left ventricular ejection fraction less than 50%.
  6. Patients with chronic obstructive pulmonary disease, heart failure, kidney failure, or other serious diseases.
  7. Pregnant women.
  8. Patients with an allergy to contrast agents.
  9. The study subjects who have metal grafts that interfere with magnetic cardiogram examination.
  10. The study subjects who are unable to cooperate with magnetocardiogram examination and CTA.
  11. Patients who have undergone coronary artery bypass grafting.
  12. There are significant artifacts present in coronary CTA.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency in comparing MCG and CT-FFR
Time Frame: 1 year
Initially, MCG was conducted on each patient to assess the extent of myocardial ischemia using magnetic field distribution, pseudo-current density distribution, magnetic field intensity time spectrum line, and magnetic couple parameters. Simultaneously, the CT-FFR cut-off value of 0.8 was employed as the benchmark for this study. The agreement, sensitivity, specificity, and positive/negative predictive value of cardiac ischemia were compared between MCG and CT-FFR.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 1 year
Firstly, we performed coronary angiography in the above patients who met the indications of coronary angiography and performed revascularization according to the intraoperative conditions. The revascularized patients were then followed up for 1 year with major adverse cardiovascular events as the endpoint. By reviewing the ratio of coronary angiography, revascularization, and incidence of MACE in enrolled patients, the value of MCG in guiding the clinical treatment of patients with stable coronary disease was evaluated.
1 year

Collaborators and Investigators

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

Sponsor

Nanhai Hospital, Guangdong Provincial People's Hospital

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 (Actual)

April 19, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GJishen

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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