search
Back to results

Magnetocardiography in the Accurate Identification of Myocardial Infarction

Primary Purpose

Chest Pain, Acute Coronary Syndrome, Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetometer
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain, Acute Coronary Syndrome, Myocardial Infarction

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

For healthy volunteers: Inclusion Criteria: 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. Exclusion Criteria: 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: Inclusion Criteria: Age 18-79 years old; 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); Sign the informed consent. Exclusion Criteria: Patients with known structural heart disease such as cardiomyopathy and valvular disease; Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal; History of other cardiovascular diseases such as pulmonary embolism and aortic dissection; Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications; Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply; Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2); Patients with malignant tumors; Professional athletes, pregnant or breastfeeding women, alcoholics; Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.; Patients with infectious diseases or infectious diseases; Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.; Unable to or fail to cooperate with the corresponding research requirements.

Sites / Locations

  • Qilu Hospital of Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

healthy volunteers

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

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Accuracy of MCG to detect the localization of myocardial infarct
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.
Accuracy of MCG in identifying myocardial infarct sizes
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.

Full Information

First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
Qilu Hospital of Shandong University
Collaborators
Hangzhou Extremely Weak Magnetic Field Large Facility Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05896826
Brief Title
Magnetocardiography in the Accurate Identification of Myocardial Infarction
Official Title
Ultra-sensitive Magnetocardiography in the Accurate Identification of Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Hangzhou Extremely Weak Magnetic Field Large Facility Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Coronary Syndrome, Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Other
Arm Title
chest pain patients who will receive ECG, biomarkers, or non-invasive imaging examination
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Magnetometer
Intervention Description
inspection equipment for magnetocardiography
Primary Outcome Measure Information:
Title
Accuracy of MCG to detect myocardial infarction
Description
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).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Accuracy of MCG to detect the localization of myocardial infarct
Description
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.
Time Frame
6 hours
Title
Accuracy of MCG in identifying myocardial infarct sizes
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For healthy volunteers: Inclusion Criteria: 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. Exclusion Criteria: 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: Inclusion Criteria: Age 18-79 years old; 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); Sign the informed consent. Exclusion Criteria: Patients with known structural heart disease such as cardiomyopathy and valvular disease; Patients with arrhythmias such as atrial fibrillation, supraventricular tachycardia, and atrioventricular block that have not returned to normal; History of other cardiovascular diseases such as pulmonary embolism and aortic dissection; Patients with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications; Obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply; Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2); Patients with malignant tumors; Professional athletes, pregnant or breastfeeding women, alcoholics; Acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.; Patients with infectious diseases or infectious diseases; Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.; Unable to or fail to cooperate with the corresponding research requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaojiao Pang, Dr.
Phone
0086-0531-82165674
Email
jiaojiaopang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguo Chen, Dr
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Li, Master
Phone
0086-0531-82160992
Email
liping0222@126.com

12. IPD Sharing Statement

Learn more about this trial

Magnetocardiography in the Accurate Identification of Myocardial Infarction

We'll reach out to this number within 24 hrs