Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial

Capital Medical University

Status: Not yet enrolling

Conditions: Stable Coronary Artery Disease CAD

Treatments: Diagnostic Test: MCG Group; Diagnostic Test: Conventional Management Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07341932

2024AZB1003 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,312 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80 years, regardless of gender.

2. Patients with stable coronary artery disease (CAD).

3. 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.

   *Note: Chest pain is characterized by the following three features:* *(1) Chest discomfort lasting less than 15 minutes;* *(2) Precipitated by physical exertion or emotional stress;* *(3) Relieved by rest or nitrates.* *Based on these, angina is classified as:*

   • *Typical angina: all 3 features are present;*
   • *Atypical angina: 2 features are present;*
   • *Non-anginal chest pain: 1 or no feature is present.*

4. Willing to participate in the study and provide written informed consent.

Exclusion criteria

1. Previous myocardial infarction, PCI, CABG, or coronary angiography indicating stenosis ≥50% in a major vessel.
2. CCTA indicating left main coronary artery stenosis >50% and/or three-vessel disease.
3. History of cardiac dysfunction (≥ NYHA Class III), severe congenital heart disease, valvular heart disease, or cardiomyopathy.
4. Complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, atrial fibrillation, atrial flutter, etc.
5. History of metal implant placement (including mechanical valves, pacemakers, orthopedic internal fixation plates, drug pumps, etc.).
6. Claustrophobia.
7. Severe thoracic deformity.
8. Active bleeding.
9. Any disease with an expected survival of less than 1 year.
10. Completion of any of the following tests prior to enrollment: exercise ECG, stress echocardiography, stress SPECT, or stress CMR.
11. Any other condition where the investigator considers the patient unsuitable for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,312 participants in 2 patient groups

Conventional Management Group

Experimental group

Description:

Treatment strategies were recommended based on stenosis severity, pre-test probability, and functional test results: For patients with 50-70% stenosis, if the pre-test probability was \<15%, treatment recommendations had to be made by clinicians integrating one or more functional test results (e.g., exercise ECG, stress echocardiography, SPECT, stress CMR); if the pre-test probability was ≥15%, it was advised to recommend treatment strategies considering functional test results. For patients with CCTA-indicated 70-90% stenosis, clinicians could directly recommend ICA or optimal medical therapy.

Treatment:

Diagnostic Test: Conventional Management Group

MCG Group

Experimental group

Description:

Based on MCG results, either ICA or optimal medical therapy was recommended.

Treatment:

Diagnostic Test: MCG Group