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

NCT06123728 | Recruiting

• 1 other identifier: GJishen
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stable Coronary Artery Disease

Keywords

stable coronary artery disease; magnetocardiography; coronary CTA

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

• Major Adverse Cardiac Events (MACE)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanhai Hospital, Guangdong Provincial People's Hospital: lead

Study Sites (1)

Nanhai Hospital, Guangdong Provincial People's Hospital

Foshan, Guangdong, China

RECRUITING

Central Study Contacts

Wenfei He

CONTACT

13380239072; nh2y_xnk@163.com

Jishen Guo

CONTACT

18027309031; guojsdoctor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: November 9, 2023
• Study Start: April 19, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)