Stable Coronary Artery Disease CADNCT07341932
Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
A study testing MCG Group and Conventional Management Group in people with Stable Coronary Artery Disease CAD, run by Beijing Anzhen Hospital at 5 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Coronary Artery Disease CAD
- What is being tested?
- MCG Group and Conventional Management Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,312 participants
- Where
- 5 sitesChina
- Study dates
- 17 Mar 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Air Force Medical Center, People's Liberation Army of China
Beijing, Beijing Municipality
Haitao Zhang, 86-010-66928118, kjzht@sina.com
- Recruiting
Beijing United Family Hospital
Beijing, Beijing Municipality
Dezhao Wang, 86-010-59277350, dezhao.w@126.com
- Recruiting
首都医科大学附属北京安贞医院
Beijing, Beijing Municipality
Xiantao Song, 86-010-64412431, tcc2033@163.com
- Not yet recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan
Zhen Zhang, 86-028-61312288, zhangzhen@swjtu.edu.cn
- Not yet recruiting
Urumqi Friendship Hospital
Ürümqi, Xinjiang Uygur Autonomous Region
Wen Bai, 86-0991-7900983, baiwen@126.com
About this study
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).
Read more
The study will proceed with the following evaluations:
- 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.
- 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.
- Conditions
- Stable Coronary Artery Disease CAD
- Being tested
- MCG Group, Conventional Management Group
- Keywords
- Stable coronary artery disease CAD, MCG, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCG GroupDiagnostic test
Based on MCG results, either ICA or optimal medical therapy was recommended.
Conventional Management GroupDiagnostic test
Treatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Management Group | Experimental | 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. Receives: Diagnostic Test: Conventional Management Group |
| MCG Group | Experimental | Based on MCG results, either ICA or optimal medical therapy was recommended. Receives: Diagnostic Test: MCG Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA)
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.
Measured: From randomization through day 90 after enrollment.
Secondary outcomes (3)
Seattle Angina Questionnaire (SAQ) Score
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.
Measured: From randomization through month 12 after enrollment.
MACE
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.
Measured: From randomization through month 12 after enrollment.
Healthcare Expenditure
Total healthcare expenditures will be collected via telephone follow-up at 7 days, 3 months, 6 months, and 12 months after enrollment.
Measured: From randomization through month 12 after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery Disease CADStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, song xiantao, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341932
- Sponsor's protocol ID
- 2024AZB1003
- Other IDs
- 2024AZB1003
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The original database will be public one year after the end of the study by uploading the EXECL electronic database.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helium-free Magnetocardiography Guided Therapy for Stable Coronary Artery Disease - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341932
- Acronym / sponsor ID
- 2024AZB1003
- Conditions
- Stable Coronary Artery Disease CAD
- Keywords
- Stable coronary artery disease CAD, MCG, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,312 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Management Group | Experimental | Diagnostic Test: Conventional Management GroupTreatment 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. |
| MCG Group | Experimental | Diagnostic Test: MCG GroupBased on MCG results, either ICA or optimal medical therapy was recommended. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Willing to participate in the study and provide written informed consent.
Key exclusion criteria (11 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCG GroupBased on MCG results, either ICA or optimal medical therapy was recommended. | Diagnostic test | MCG Group |
| Conventional Management GroupTreatment strategy is recommended based on stenosis severity, pre-test probability, and results of functional tests. | Diagnostic test | Conventional Management Group |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. The original database will be public one year after the end of the study by uploading the EXECL electronic database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCG Group and Conventional Management Group in people with Stable Coronary Artery Disease CAD, run by Beijing Anzhen Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiantao Song (86-010-64412431, tcc2033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with non-obstructive coronary artery disease on invasive coronary angiography (ICA) (time frame: From randomization through day 90 after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.