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

April 1, 2026 updated by: song xiantao, Beijing Anzhen Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Air Force Medical Center, People's Liberation Army of China
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing United Family Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • 首都医科大学附属北京安贞医院
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • The Third People's Hospital of Chengdu
        • Contact:
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China
        • Not yet recruiting
        • Urumqi Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Management Group
Treatment strategies were recommended based on stenosis severity, pre-test probability, and functional test results: For patients with 50-70% stenosis, if the pre-test probability was <15%, treatment recommendations had to be made by clinicians integrating one or more functional test results (e.g., exercise ECG, stress echocardiography, SPECT, stress CMR); if the pre-test probability was ≥15%, it was advised to recommend treatment strategies considering functional test results. For patients with CCTA-indicated 70-90% stenosis, clinicians could directly recommend ICA or optimal medical therapy.
Diagnostic test: Conventional Management Group
Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
Experimental: MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.
Diagnostic test: MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)
Time Frame: From randomization through day 90 after enrollment.
Compare the proportion of patients with non-obstructive coronary artery disease on planned invasive coronary angiography (ICA) performed within 90 days between the MCG-guided group and the conventional management group, where non-obstructive disease is defined as coronary stenosis <70% or an invasive fractional flow reserve (FFR) value ≥0.8.
From randomization through day 90 after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seattle Angina Questionnaire (SAQ) Score
Time Frame: From randomization through month 12 after enrollment.
Patient quality of life will be assessed using the Seattle Angina Questionnaire (SAQ) at enrollment and at 3, 6, and 12 months thereafter. The assessment covers five domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception.
From randomization through month 12 after enrollment.
MACE
Time Frame: From randomization through month 12 after enrollment.
The occurrence of Major Adverse Cardiovascular Events (MACE) will be recorded at 3, 6, and 12 months after enrollment. MACE is defined for this study as a composite of the following: hospitalization for unstable angina, unplanned revascularization beyond 90 days, non-fatal myocardial infarction (MI), and cardiac death.
From randomization through month 12 after enrollment.
Healthcare Expenditure
Time Frame: From randomization through month 12 after enrollment.
Total healthcare expenditures will be collected via telephone follow-up at 7 days, 3 months, 6 months, and 12 months after enrollment.
From randomization through month 12 after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024AZB1003 (Other Grant/Funding Number: Beijing Anzhen Hosptial, Capital Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The original database will be public one year after the end of the study by uploading the EXECL electronic database.

IPD Sharing Time Frame

The raw data will be made publicly available starting 1 year after study completion and will remain accessible for a period of 5 years.

IPD Sharing Access Criteria

Physicians in the relevant field may access the Individual Participant Data (IPD) and supporting information. The study protocol, informed consent forms, and raw data are available upon request via email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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