Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
NCT ID: NCT07341932
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1312 participants
INTERVENTIONAL
2025-12-27
2027-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Conventional Management Group
Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.
MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.
Interventions
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Conventional Management Group
Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
MCG Group
Based on MCG results, either ICA or optimal medical therapy was recommended.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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song xiantao
Director of Cardiology Ward A, Department of Cardiology I
Locations
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Air Force Medical Center, People's Liberation Army of China
Beijing, Beijing Municipality, China
Beijing United Family Hospital
Beijing, Beijing Municipality, China
首都医科大学附属北京安贞医院
Beijing, Beijing Municipality, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
Urumqi Friendship Hospital
Ürümqi, Xinjiang Uygur Autonomous Region, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024AZB1003
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024AZB1003
Identifier Type: -
Identifier Source: org_study_id
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