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

NCT07341932 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Anzhen Hospital

Phase

Not applicable

Started

2026-03-17

Last updated

2026-04-02

Condition(s) studied

Stable Coronary Artery Disease CAD

Investigational drug(s) / intervention(s)

MCG GroupConventional Management Group

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

Conventional Management Group: Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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.

Primary outcome measure(s)

Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA) — From randomization through day 90 after enrollment.
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.

Trial sites (5)

Facility	City	Region	Status
Air Force Medical Center, People's Liberation Army of China	Beijing	Beijing Municipality	Not Yet Recruiting
Beijing United Family Hospital	Beijing	Beijing Municipality	Recruiting
首都医科大学附属北京安贞医院	Beijing	Beijing Municipality	Recruiting
The Third People's Hospital of Chengdu	Chengdu	Sichuan	Not Yet Recruiting
Urumqi Friendship Hospital	Ürümqi	Xinjiang Uygur Autonomous Region	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07341932 on ClinicalTrials.gov ↗ ← All trials in China