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RecruitingNCT06123728Updated Jun 4, 2024

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

An observational study in Stable Coronary Artery Disease, sponsored by Nanhai Hospital, Guangdong Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Nanhai Hospital, Guangdong Provincial People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
291
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Stable Coronary Artery Disease

Keywords

  • stable coronary artery disease
  • magnetocardiography
  • coronary CTA
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 291 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with Nanhai Hospital, Guangdong Provincial People's Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
291 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Consistency in comparing MCG and CT-FFR

    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.

    Time frame: 1 year

Secondary outcomes

  1. Major Adverse Cardiac Events (MACE)

    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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Nanhai Hospital, Guangdong Provincial People's Hospital
    Foshan, Guangdong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06123728
Lead sponsor
Nanhai Hospital, Guangdong Provincial People's Hospital
Responsible party
Sponsor
First posted
Nov 9, 2023
Start date
Apr 19, 2023
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jun 4, 2024

Study contacts

Wenfei He
Contact
nh2y_xnk@163.com
13380239072
Jishen Guo
Contact
guojsdoctor@163.com
18027309031

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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