NCT06123728

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 291 (estimated)
• Sponsor: Nanhai Hospital, Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stable Coronary Artery Disease

Timeline

• Start date: 2023-04-19
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-11-09
• Last updated: 2024-06-04

Locations

1 site across 1 country: China