Helium-free magnetocardiography to guide care for stable coronary artery disease

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

This trial will test whether a helium-free magnetocardiography scan can help guide treatment decisions and improve outcomes for people aged 18–80 with stable coronary artery disease and 50–90% stenosis on coronary CTA.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1312 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT07341932 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter trial enrolls adults with stable CAD and at least one 50–90% stenosis on coronary CTA and assigns them 1:1 to either MCG-guided management or conventional care. In the MCG arm, treatment recommendations for invasive coronary angiography or optimal medical therapy are based on magnetocardiography results, while the control arm uses standard assessment of stenosis severity, pre-test probability, and functional test results. Randomization is stratified by study center using a central web-based system to reflect real-world clinical pathways across participating Beijing hospitals. The study aims to see if MCG-guided care can streamline clinical decision-making, improve quality of life, and reduce healthcare costs compared with conventional management.

Who should consider this trial

Good fit: Adults 18–80 with stable coronary artery disease who have at least one 50–90% coronary stenosis on CTA (with symptomatic criteria required for 50–69% lesions) and who can give informed consent are ideal candidates.

Not a fit: Patients with prior myocardial infarction, prior PCI or CABG, acute coronary syndromes, or without qualifying coronary CTA stenosis are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, MCG-guided care could reduce unnecessary invasive angiography, improve patients' quality of life, and lower healthcare costs.

How similar studies have performed: Magnetocardiography is a relatively novel approach for guiding coronary care: small feasibility studies exist but randomized evidence for MCG-guided decision pathways is limited.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 4 other locations

• Air Force Medical Center, People's Liberation Army of China — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing United Family Hospital — Beijing, Beijing Municipality, China (Recruiting)
• 首都医科大学附属北京安贞医院 — Beijing, Beijing Municipality, China (Recruiting)
• The Third People's Hospital of Chengdu — Chengdu, Sichuan, China (Not_yet_recruiting)
• Urumqi Friendship Hospital — Ürümqi, Xinjiang Uygur Autonomous Region, China (Not_yet_recruiting)

Study contacts

• Study coordinator: xiantao Song

Conditions Stable Coronary Artery Disease CAD; Stable coronary artery disease CAD; MCG; Randomized Controlled Trial