Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
Conditions
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.
Interventions
DEVICEMagnetometer
inspection equipment for magnetocardiography
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Weifang People's Hospital
Linyi People's Hospital
Jining First People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital Xi'an Jiaotong University
Chongqing Emergency Medical Center
Guangdong Provincial Hospital of Traditional Chinese Medicine
First People's Hospital of Hangzhou
Qianfoshan Hospital
Weihai Central Hospital
Heze Municipal Hospital
Qilu Hospital of Shandong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion 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 undergo CAG or CTA: 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 CAG or coronary CTA; 3. Sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of MCG to detect coronary lesion | 24 hours | To establish an algorithm model of MCG in detecting coronary lesion and to assess the sensitivity and specificity of the above model in detecting coronary lesion. Coronary lesion is measured by degree of stenosis via CAG/CTA and computer-simulated fraction flow reserve via QFR/CTFFR. |
| Accuracy of MCG to detect myocardial necrosis | 24 hours | To establish an algorithm model of MCG in detecting myocardial necrosis and to assess the sensitivity and specificity of this model in detecting myocardial necrosis, which is measured via cardiac MR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of MCG to detect the localization of coronary lesion | 24 hours | To build up an algorithm model of MCG in detecting the localization of coronary lesion. Assess the sensitivity and specificity of this model to detect the main vessels where the lesion locates. |
| Accuracy of MCG to detect the zone of myocardial necrosis | 24 hours | To establish an algorithm model of MCG to detect the infarct zone of the heart. Assess the sensitivity and specificity of this model to detect the location of myocardial necrosis. |
Countries
China
Contacts
Primary ContactJiaojiao Pang, Dr.
Outcome results
None listed