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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Air Force Medical Center, People's Liberation Army of China
  Beijing, Beijing Municipality, China Not yet 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
• Email: tcc2033@163.com
• Phone: 86-010-64412431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.