Chest PainNCT05896826
Magnetocardiography in the Accurate Identification of Myocardial Infarction
An observational study of Chest Pain and Acute Coronary Syndrome, 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 infarction. 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
- How many people
- 3,841 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Dec 2026
- Phase
- Observational
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy individuals and chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination
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 electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography);
- 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 receive ECG, biomarkers, or non-invasive imaging examination:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiaojiao Pang, Doctor, 0086-0531-82165398, jiaojiaopang@126.com
About this study
Official title: Ultra-sensitive Magnetocardiography in the Accurate Identification of Myocardial Infarction
Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial infarction. 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 myocardial infarction. Myocardial infarction are diagnosed by electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography). Myocardial infarction is also quantified by cardiac magnetic resonance or single-photon-emission tomography. Healthy volunteers and chest pain patients who will receive electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography) examination will be enrolled in this study.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
- 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 | Not described Receives: Device: Magnetometer | |
| chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination | 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 myocardial infarction
To establish an algorithm model of MCG in detecting myocardial infarction and to assess the sensitivity and specificity of the above model in detecting myocardial infarction. Myocardial infarction are diagnosed by electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography).
Measured: 6 hours
Secondary outcomes (2)
Accuracy of MCG to detect the localization of myocardial infarct
To build up an algorithm model of MCG in detecting the localization of myocardial infarct. The sensitivity and specificity of the model in detecting infarct location were evaluated.
Measured: 6 hours
Accuracy of MCG in identifying myocardial infarct sizes
To establish an algorithm model of MCG in detecting identifying myocardial infarct sizes and to assess the sensitivity and specificity of the above model in identifying myocardial infarct sizes. Myocardial infarction sizes is quantified by cardiac magnetic resonance or single-photon-emission tomography.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,841 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Emergency Medical Center, Weifang People's Hospital, Linyi People's Hospital, Weihai Central 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, Guangdong Provincial Hospital of Traditional Chinese Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Qianfoshan Hospital, Heze Municipal Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Dr, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896826
- Sponsor's protocol ID
- QLEmer-MCG
- Status last verified
- Sep 2025
- First submitted
- 31 May 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-sensitive Magnetocardiography in the Accurate Identification of Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05896826
- Acronym / sponsor ID
- QLEmer-MCG
- Conditions
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,841 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Chongqing Emergency Medical Center, Weifang People's Hospital, Linyi People's Hospital, Weihai Central 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, Guangdong Provincial Hospital of Traditional Chinese Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Qianfoshan Hospital, Heze Municipal Hospital, First People's Hospital of Hangzhou
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Jun 2023 (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 infarction. 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 myocardial infarction. Myocardial infarction are diagnosed by electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography). Myocardial infarction is also quantified by cardiac magnetic resonance or single-photon-emission tomography. Healthy volunteers and chest pain patients who will receive electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography) examination will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Device: Magnetometer |
| chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination | – | Device: Magnetometer |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy individuals and chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination
Key inclusion criteria (7 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 (26 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 | chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination, healthy volunteers |
Primary outcome
Accuracy of MCG to detect myocardial infarction
Time frame: 6 hours
To establish an algorithm model of MCG in detecting myocardial infarction and to assess the sensitivity and specificity of the above model in detecting myocardial infarction. Myocardial infarction are diagnosed by electrocardiogram, biomarkers (high-sensitivity cardiac troponin, etc), or non-invasive imaging (cardiac magnetic resonance or single-photon-emission tomography).
2 secondary outcomes
Accuracy of MCG to detect the localization of myocardial infarct
Time frame: 6 hours
Accuracy of MCG in identifying myocardial infarct sizes
Time frame: 6 hours
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 Oct 2025.
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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.
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?
An observational study of Chest Pain and Acute Coronary Syndrome, 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 7 inclusion and 26 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 Oct 2025. 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?
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 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 myocardial infarction (time frame: 6 hours). 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 Oct 2025.