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NCT07341932Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1312 (estimated)
First submitted
6 Jan 2026
Start date
17 Mar 2026
Primary completion date
1 Jun 2027
Lead sponsor
Beijing Anzhen Hospital
NCT number
NCT07341932

What you commit to

  • Study type: Interventional
  • Planned participants: 1312
  • From 17 Mar 2026 to the primary completion date, 1 Jun 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous myocardial infarction, PCI, CABG, or coronary angiography indicating stenosis ≥50% in a major vessel.
  • Completion of any of the following tests prior to enrollment: exercise ECG, stress echocardiography, stress SPECT, or stress CMR.

Other illness

  • CCTA indicating left main coronary artery stenosis \>50% and/or three-vessel disease.
  • History of cardiac dysfunction (≥ NYHA Class III), severe congenital heart disease, valvular heart disease, or cardiomyopathy.
  • Complex arrhythmias, such as frequent atrial premature beats, ventricular premature beats, atrial fibrillation, atrial flutter, etc.
  • History of metal implant placement (including mechanical valves, pacemakers, orthopedic internal fixation plates, drug pumps, etc.).
  • Active bleeding.
  • Any disease with an expected survival of less than 1 year.
  • Any other condition where the investigator considers the patient unsuitable for this study.

Other

  • Claustrophobia.
  • Severe thoracic deformity.

Who the study is looking for

  • Age 18-80 years, regardless of gender.
  • Patients with stable coronary artery disease (CAD).
  • 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.\*
  • Willing to participate in the study and provide written informed consent.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Beijing United Family Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Air Force Medical Center, People's Liberation Army of China
Coordinator of this site? Confirm its status
BeijingChinaNot yet recruiting
The Third People's Hospital of Chengdu
Coordinator of this site? Confirm its status
ChengduChinaNot yet recruiting
Urumqi Friendship Hospital
Coordinator of this site? Confirm its status
ÜrümqiChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.