Chest Pain, Acute Coronary Syndrome, Myocardial InfarctionNCT05392712
Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis
A study testing Magnetometer in people with Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial ischemia. Although progress has been made in this area, there is a lack of studies using up-to-date examination instruments for the calibration of MCG analysis. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Magnetometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-79 years old;
- No history of cardiovascular disease (coronary heart disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic dissection, etc.), no cardiovascular risk factors (hypertension, diabetes, hyperlipidemia). For people over 65 years old, those with hypertension or hyperlipidemia, but with well-controlled blood pressure and lipid levels, taking no more than 2 drugs, and echocardiography showing no left ventricular hypertrophy, can be included;
- The electrocardiogram is normal, and the cardiac ultrasound is basically normal in the past 1 year (mild valvular regurgitation can be included).
- Sign the informed consent.
- Age 18-79 years old;
- Those with chest pain symptoms, diagnosed or highly suspected by the attending doctor or above as stable angina pectoris (SA), unstable angina pectoris (UA), non-ST segment elevation myocardial infarction (NSTEMI), ST segment elevation myocardial infarction (STEMI), and plan to receive CAG or coronary CTA;
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- Sign the informed consent.
- Age 18-79 years old;
- The attending doctor or above has diagnosed the patient as acute myocardial infarction (NSTEMI, STEMI), the condition of whom is relatively stable, and CMR examination is feasible after evaluation.
- Sign the informed consent.
Who cannot join
- Those who with acute or chronic respiratory diseases;
- Those who with obvious abnormality of liver or kidney function;
- Those who with endocrine diseases such as abnormal thyroid function;
- Those who with anemia or other blood diseases;
- Those who with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.);
- Those who are obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
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- Those who with malignant tumors;
- Those who with infectious diseases or infectious diseases;
- Those who with trauma or physical disability;
- Those who with psychological or mental illness such as depression;
- Those who are professional athletes, pregnant or breastfeeding women, alcoholics;
- Those who are unable to perform magnetocardiography examination due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
- Due to various reasons such as allergy to contrast agents, metal implants in vivo that are prohibited from performing 1.5T MRI (such as prostheses or steel plates implanted in orthopaedics, uterine contraceptive device) and other reasons, those who cannot or fail to cooperate with the corresponding research requirements.
- For chest pain patients who will undergo CAG or CTA:
- Patients with known structural heart disease such as cardiomyopathy and valvular disease;
- Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal;
- History of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
- Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
- Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
- Patients with malignant tumors;
- Professional athletes, pregnant or breastfeeding women, alcoholics;
- Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
- Patients with infectious diseases or infectious diseases;
- Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
- Unable to or fail to cooperate with the corresponding research requirements.
- For AMI patients:
- Patients with known structural heart disease such as cardiomyopathy and valvular disease;
- Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal;
- History of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
- Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
- Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
- Patients with malignant tumors;
- Professional athletes, pregnant or breastfeeding women, alcoholics;
- Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
- Patients with infectious diseases or infectious diseases;
- Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
- Due to various reasons such as allergy to contrast agents, metal implants in vivo that are prohibited from performing 1.5T MRI (such as prostheses or steel plates implanted in orthopaedics, uterine contraceptive device) and other reasons, those who cannot or fail to cooperate with the corresponding research requirements.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Ping Li, Master, 0086-0531-82160992, liping0222@126.com
About this study
Official title: Ultra-sensitive Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis
Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial ischemia. Although progress has been made in this area, there is a lack of studies using up-to-date examination instruments for the calibration of MCG analysis. This is a prospective single-center study aiming to build accurate analytical models of MCG to detect coronary lesions and myocardial necrosis. Coronary lesions are measured by coronary angiography (CAG) or coronary CTA, and are defined by both the stenosis degree and the computer-simulated fraction flow reserve. Myocardial necrosis is examined and quantified by cardiac MR. Healthy volunteers, chest pain patients who will receive CAG or CTA examination, and patients with acute myocardial infarction will be enrolled in this study.
- Being tested
- Magnetometer
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetometerDevice
inspection equipment for magnetocardiography
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | Not described Receives: Device: Magnetometer |
| Chest pain patients who will undergo CAG or CTA | Experimental | Not described Receives: Device: Magnetometer |
| AMI patients | Experimental | Not described Receives: Device: Magnetometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MCG to detect coronary lesion
To establish an algorithm model of MCG in detecting coronary lesion and to assess the sensitivity and specificity of the above model in detecting coronary lesion. Coronary lesion is measured by degree of stenosis via CAG/CTA and computer-simulated fraction flow reserve via QFR/CTFFR.
Measured: 24 hours
Accuracy of MCG to detect myocardial necrosis
To establish an algorithm model of MCG in detecting myocardial necrosis and to assess the sensitivity and specificity of this model in detecting myocardial necrosis, which is measured via cardiac MR.
Measured: 24 hours
Secondary outcomes (2)
Accuracy of MCG to detect the localization of coronary lesion
To build up an algorithm model of MCG in detecting the localization of coronary lesion. Assess the sensitivity and specificity of this model to detect the main vessels where the lesion locates.
Measured: 24 hours
Accuracy of MCG to detect the zone of myocardial necrosis
To establish an algorithm model of MCG to detect the infarct zone of the heart. Assess the sensitivity and specificity of this model to detect the location of myocardial necrosis.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Pain, Acute Coronary Syndrome, Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Weifang People's Hospital, Linyi People's Hospital, Jining First People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, Chongqing Emergency Medical Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Qianfoshan Hospital, Weihai Central Hospital, Heze Municipal Hospital
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Dr, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392712
- Sponsor's protocol ID
- QLEmer-Magneto 1
- Status last verified
- May 2024
- First submitted
- 23 May 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang R, Liu Z, Pang J, Sun J, Xiang M, Ning X. SkipDAEformer: A High-Precision Representation Learning Method for Removing Random Mixed Noise in MCG Signals. IEEE J Biomed Health Inform. 2025 Nov;29(11):8086-8099. doi: 10.1109/JBHI.2025.3579060.
PubMed 40498621
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-sensitive Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis
- ClinicalTrials.gov ID
- NCT05392712
- Acronym / sponsor ID
- QLEmer-Magneto 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Weifang People's Hospital, Linyi People's Hospital, Jining First People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, Chongqing Emergency Medical Center, Guangdong Provincial Hospital of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Qianfoshan Hospital, Weihai Central Hospital, Heze Municipal Hospital
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 May 2022 (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.
Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial ischemia. Although progress has been made in this area, there is a lack of studies using up-to-date examination instruments for the calibration of MCG analysis. This is a prospective single-center study aiming to build accurate analytical models of MCG to detect coronary lesions and myocardial necrosis. Coronary lesions are measured by coronary angiography (CAG) or coronary CTA, and are defined by both the stenosis degree and the computer-simulated fraction flow reserve. Myocardial necrosis is examined and quantified by cardiac MR. Healthy volunteers, chest pain patients who will receive CAG or CTA examination, and patients with acute myocardial infarction will be enrolled in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Device: Magnetometer |
| Chest pain patients who will undergo CAG or CTA | Experimental | Device: Magnetometer |
| AMI patients | Experimental | Device: Magnetometer |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-79 years old;
- No history of cardiovascular disease (coronary heart disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic dissection, etc.), no cardiovascular risk factors (hypertension, diabetes, hyperlipidemia). For people over 65 years old, those with hypertension or hyperlipidemia, but with well-controlled blood pressure and lipid levels, taking no more than 2 drugs, and echocardiography showing no left ventricular hypertrophy, can be included;
- The electrocardiogram is normal, and the cardiac ultrasound is basically normal in the past 1 year (mild valvular regurgitation can be included).
- Sign the informed consent.
- Age 18-79 years old;
Key exclusion criteria (39 listed)
- Those who with acute or chronic respiratory diseases;
- Those who with obvious abnormality of liver or kidney function;
- Those who with endocrine diseases such as abnormal thyroid function;
- Those who with anemia or other blood diseases;
- Those who with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, 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 |
|---|---|---|
| Magnetometerinspection equipment for magnetocardiography | Device | AMI patients, Chest pain patients who will undergo CAG or CTA, healthy volunteers |
Primary outcome
Accuracy of MCG to detect coronary lesion
Time frame: 24 hours
To establish an algorithm model of MCG in detecting coronary lesion and to assess the sensitivity and specificity of the above model in detecting coronary lesion. Coronary lesion is measured by degree of stenosis via CAG/CTA and computer-simulated fraction flow reserve via QFR/CTFFR.
Accuracy of MCG to detect myocardial necrosis
Time frame: 24 hours
To establish an algorithm model of MCG in detecting myocardial necrosis and to assess the sensitivity and specificity of this model in detecting myocardial necrosis, which is measured via cardiac MR.
2 secondary outcomes
Accuracy of MCG to detect the localization of coronary lesion
Time frame: 24 hours
Accuracy of MCG to detect the zone of myocardial necrosis
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 40498621Wang R, Liu Z, Pang J, Sun J, Xiang M, Ning X. SkipDAEformer: A High-Precision Representation Learning Method for Removing Random Mixed Noise in MCG Signals. IEEE J Biomed Health Inform. 2025 Nov;29(11):8086-8099. doi: 10.1109/JBHI.2025.3579060.
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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. This study is not recruiting at the moment.
Yuguo Chen, Dr principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetometer in people with Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, run by Qilu Hospital of Shandong University at 1 site 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 10 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaojiao Pang, Dr. (0086-0531-82165674, jiaojiaopang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of MCG to detect coronary lesion (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392712, which also lists 1 linked publication.
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 22 Aug 2024.