Clinical trial NCT05896826: Magnetocardiography in the Accurate Identification of Myocardial Infarction
Official title: Ultra-sensitive Magnetocardiography in the Accurate Identification of Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chest Pain
Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Chongqing Emergency Medical Center
name: Weifang People's Hospital
name: Linyi People's Hospital
name: Weihai Central Hospital
name: Jining First People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Qianfoshan Hospital
name: Heze Municipal Hospital
name: First People's Hospital of Hangzhou
First posted: 2023-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy individuals and chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of MCG to detect myocardial infarction
timeFrame: 6 hours
Secondary outcomes:
measure: Accuracy of MCG to detect the localization of myocardial infarct
timeFrame: 6 hours
measure: Accuracy of MCG in identifying myocardial infarct sizes
timeFrame: 6 hours
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yuguo Chen, Dr
role: PRINCIPAL_INVESTIGATOR
References: