This rigorously designed randomized controlled trial aims to investigate whether Magnetocardiography (MCG) can optimize the clinical pathway, improve quality of life, and reduce healthcare costs in patients with stable coronary artery disease (SCAD) within real-world clinical settings, thereby generating evidence for the future application of MCG in clinical decision-making pathways.
Stable CAD patients with at least one major coronary vessel showing 50%-90% stenosis on coronary CTA will be enrolled based on predefined criteria. Stratified by study center and using a central web-based randomization system, participants will be allocated in a 1:1 ratio to either the \*\*MCG-guided group\*\* (where treatment recommendations for invasive coronary angiography \[ICA\] or optimal medical therapy are based on MCG results) or the \*\*conventional management group\*\* (where treatment strategy is based on stenosis severity, pre-test probability, and functional test results).
The study will proceed with the following evaluations:
1. Compare the proportion of patients with non-obstructive coronary artery disease on planned ICA performed within 90 days between the two groups, testing the hypothesis that this proportion is lower in the MCG-guided group. 2. Conduct telephone follow-ups at 90 days, 6 months, and 12 months post-enrollment to compare between-group differences in the rate of Major Adverse Cardiovascular Events (MACE), Seattle Angina Questionnaire (SAQ) scores, and total healthcare expenditures during the follow-up period.
Age 18-80 years, regardless of gender.
Patients with stable coronary artery disease (CAD).
Coronary computed tomography angiography (CCTA) shows at least one major coronary vessel (diameter ≥2.5 mm) with 50-90% stenosis. Patients with 50-69% stenosis must have typical or atypical angina; for those with 70-90% stenosis, the presence of chest pain symptoms is not required.
*Typical angina: all 3 features are present;*
Previous myocardial infarction, PCI, CABG, or coronary angiography indicating stenosis ≥50% in a major vessel.
CCTA indicating left main coronary artery stenosis >50% and/or three-vessel disease.
History of cardiac dysfunction (≥ NYHA Class III), severe congenital heart disease, valvular heart disease, or cardiomyopathy.
Complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, atrial fibrillation, atrial flutter, etc.
Parallel
MCG Group
Diagnostic testBased on MCG results, either ICA or optimal medical therapy was recommended.
Conventional Management Group
Diagnostic testTreatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)
Compare the proportion of patients with non-obstructive coronary artery disease on planned invasive coronary angiography (ICA) performed within 90 days between the MCG-guided group and the conventional management group, where non-obstructive disease is defined as coronary stenosis \<70% or an invasive fractional flow reserve (FFR) value ≥0.8.
Seattle Angina Questionnaire (SAQ) Score
Patient quality of life will be assessed using the Seattle Angina Questionnaire (SAQ) at enrollment and at 3, 6, and 12 months thereafter. The assessment covers five domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception.
MACE
The occurrence of Major Adverse Cardiovascular Events (MACE) will be recorded at 3, 6, and 12 months after enrollment. MACE is defined for this study as a composite of the following: hospitalization for unstable angina, unplanned revascularization beyond 90 days, non-fatal myocardial infarction (MI), and cardiac death.
Healthcare Expenditure
Total healthcare expenditures will be collected via telephone follow-up at 7 days, 3 months, 6 months, and 12 months after enrollment.
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