Actively Recruiting
Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
Led by Beijing Anzhen Hospital · Updated on 2026-04-02
1312
Participants Needed
5
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any gender
- Diagnosed with stable coronary artery disease
- Coronary CTA shows 50%-90% narrowing in at least one major coronary artery (diameter ≥2.5 mm)
- For 50%-69% narrowing, must have typical or atypical angina
- For 70%-90% narrowing, chest pain symptoms are not required
- Willing to participate and provide written informed consent
You will not qualify if you...
- Previous myocardial infarction, PCI, CABG, or coronary angiography showing ≥50% narrowing in a major vessel
- Left main coronary artery narrowing >50% or three-vessel disease on coronary CTA
- History of severe heart dysfunction (NYHA Class III or higher), severe congenital heart disease, valvular heart disease, or cardiomyopathy
- Complex arrhythmias such as frequent atrial or ventricular premature beats, atrial fibrillation, or atrial flutter
- History of metal implants including mechanical valves, pacemakers, orthopedic plates, or drug pumps
- Claustrophobia
- Severe chest deformity
- Active bleeding
- Any disease with expected survival less than 1 year
- Completed exercise ECG, stress echocardiography, stress SPECT, or stress CMR before enrollment
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Air Force Medical Center, People's Liberation Army of China
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Beijing United Family Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
首都医科大学附属北京安贞医院
Beijing, Beijing Municipality, China
Actively Recruiting
4
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
Not Yet Recruiting
5
Urumqi Friendship Hospital
Ürümqi, Xinjiang Uygur Autonomous Region, China
Not Yet Recruiting
Research Team
X
xiantao Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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