Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MCG Group, Conventional Management Group.
- Who it may be relevant to
- Registry conditions: Stable Coronary Artery Disease CAD. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended. - Diagnostic test Conventional Management Group
Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
Primary outcome measures
- Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA) [Time frame: From randomization through day 90 after enrollment.]
Secondary outcome measures (3)
- Seattle Angina Questionnaire (SAQ) Score [Time frame: From randomization through month 12 after enrollment.]
- MACE [Time frame: From randomization through month 12 after enrollment.]
- Healthcare Expenditure [Time frame: From randomization through month 12 after enrollment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Previous myocardial infarction, PCI, CABG, or coronary angiography indicating stenosis ≥50% in a major vessel.
- 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.).
- Claustrophobia.
- Severe thoracic deformity.
- Active bleeding.
- Any disease with an expected survival of less than 1 year.
- Completion of any of the following tests prior to enrollment: exercise ECG, stress echocardiography, stress SPECT, or stress CMR.
- Any other condition where the investigator considers the patient unsuitable for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Air Force Medical Center, People's Liberation Army of China — Beijing
- Beijing United Family Hospital — Beijing
- 首都医科大学附属北京安贞医院 — Beijing
- The Third People's Hospital of Chengdu — Chengdu
- Urumqi Friendship Hospital — Ürümqi
Identifiers
NCT: NCT07341932 · 2024AZB1003 · 2024AZB1003