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Clinical Trials/NCT05896826
NCT05896826
Recruiting
Not Applicable

Ultra-sensitive Magnetocardiography in the Accurate Identification of Myocardial Infarction

Qilu Hospital of Shandong University1 site in 1 country3,841 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chest Pain
Sponsor
Qilu Hospital of Shandong University
Enrollment
3841
Locations
1
Primary Endpoint
Accuracy of MCG to detect myocardial infarction
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Accuracy of MCG to detect myocardial infarction

Time Frame: 6 hours

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 Outcomes

  • Accuracy of MCG to detect the localization of myocardial infarct(6 hours)
  • Accuracy of MCG in identifying myocardial infarct sizes(6 hours)

Study Sites (1)

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