Magnetocardiography in the Accurate Identification of Myocardial Infarction

NCT05896826 | Recruiting DMC

• 1 other identifier: QLEmer-MCG
• Study Type: observational
• Target: 3,841
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  6 hours

Secondary Outcomes (2)

• Accuracy of MCG to detect the localization of myocardial infarct

  6 hours

• Accuracy of MCG in identifying myocardial infarct sizes

  6 hours

Study Arms (2)

healthy volunteers

Device: Magnetometer

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

Device: Magnetometer

Interventions

Magnetometer DEVICE

inspection equipment for magnetocardiography

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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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:
• Age 18-79 years old;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Chongqing Emergency Medical Center: collaborator
• Weifang People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Weihai Central Hospital: collaborator
• Jining First People's Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Qianfoshan Hospital: collaborator
• Heze Municipal Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Yuguo Chen, Dr

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Dr.

CONTACT

0086-0531-82165674; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 1, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)