Magnetocardiography in the Accurate Identification of Myocardial Infarction

September 27, 2025 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3841

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

healthy individuals and chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination

Description

For healthy volunteers:

Inclusion Criteria:

  1. Age 18-79 years old;
  2. 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;
  3. The electrocardiogram is normal, and the cardiac ultrasound is basically normal in the past 1 year (mild valvular regurgitation can be included).
  4. Sign the informed consent.

Exclusion Criteria:

  1. Those who with acute or chronic respiratory diseases;
  2. Those who with obvious abnormality of liver or kidney function;
  3. Those who with endocrine diseases such as abnormal thyroid function;
  4. Those who with anemia or other blood diseases;
  5. Those who with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.);
  6. Those who are obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
  7. Those who with malignant tumors;
  8. Those who with infectious diseases or infectious diseases;
  9. Those who with trauma or physical disability;
  10. Those who with psychological or mental illness such as depression;
  11. Those who are professional athletes, pregnant or breastfeeding women, alcoholics;
  12. Those who are unable to perform magnetocardiography examination due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
  13. 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:

Inclusion Criteria:

  1. Age 18-79 years old;
  2. 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);
  3. Sign the informed consent.

Exclusion Criteria:

  1. Patients with known structural heart disease such as cardiomyopathy and valvular disease;
  2. Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal;
  3. History of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
  4. Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
  5. Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
  6. Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
  7. Patients with malignant tumors;
  8. Professional athletes, pregnant or breastfeeding women, alcoholics;
  9. Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
  10. Patients with infectious diseases or infectious diseases;
  11. Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
  12. Unable to or fail to cooperate with the corresponding research requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy volunteers
Device: Magnetometer
inspection equipment for magnetocardiography
chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination
Device: Magnetometer
inspection equipment for magnetocardiography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of MCG to detect the localization of myocardial infarct
Time Frame: 6 hours
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.
6 hours
Accuracy of MCG in identifying myocardial infarct sizes
Time Frame: 6 hours
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.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
First People's Hospital of Hangzhou
Guangdong Provincial Hospital of Traditional Chinese Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital Xi'an Jiaotong University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Qianfoshan Hospital
Linyi People's Hospital
Weifang People's Hospital
Chongqing Emergency Medical Center
Weihai Central Hospital
Heze Municipal Hospital
Jining First People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuguo Chen, Dr, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QLEmer-MCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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