Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07341932

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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