Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis

NCT ID: NCT05392712

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2024-12-30

Brief 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. 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.

Conditions

Chest Pain, Acute Coronary Syndrome, Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

healthy volunteers

Group Type: OTHER

Magnetometer

Intervention Type: DEVICE

inspection equipment for magnetocardiography

Chest pain patients who will undergo CAG or CTA

Group Type: EXPERIMENTAL

Magnetometer

Intervention Type: DEVICE

inspection equipment for magnetocardiography

AMI patients

Group Type: EXPERIMENTAL

Magnetometer

Intervention Type: DEVICE

inspection equipment for magnetocardiography

Interventions

Magnetometer

inspection equipment for magnetocardiography

Intervention Type: DEVICE

Eligibility Criteria

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.

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 CAG or coronary CTA;

3. Sign the informed consent.

1. Age 18-79 years old;

2. 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.

3. 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 undergo CAG or CTA:

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.

For AMI patients:

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. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Weifang People's Hospital

OTHER

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Jining First People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Chongqing Emergency Medical Center

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Weihai Central Hospital

OTHER

Sponsor Role: collaborator

Heze Municipal Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuguo Chen, Dr

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiaojiao Pang, Dr.

Role: CONTACT

jiaojiaopang@126.com

0086-0531-82165674

Facility Contacts

Ping Li, Master

Role: primary

liping0222@126.com

0086-0531-82160992

Other Identifiers

QLEmer-Magneto 1

Identifier Type: -

Identifier Source: org_study_id