The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.
Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.
Study Type
OBSERVATIONAL
Enrollment
14,090
Magnetocardiography
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGEfficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.
A normal ECG is determined by two cardiologists with over five years of working experience. If there is any objection, the decision shall be made by a third cardiologist of the same qualifications or above. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Time frame: from the date of enrollment until the date of discharge, up to 30 days
The time saved by using MCG in the detection of NSTEMI compared to troponin
The time for the detection of NSTEMI is from the timepoint of first medical contact to the timepoint of MCG report showing ischemia or the first report of troponin that over the 99th percentile of the Upper reference limit (URL).
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in evaluating the severity of coronary lesions.
The severity of coronary lesions is determined by using CAG/CTA and fractional flow reserve. Severe degree is defined as ≥90% stenosis of at least one main vessel or branch vessel with diameter ≥2mm. Moderate degree is defined as 50%-89% stenosis and fractional flow reserve ≤0.8. Mild degree is defined as \<50% stenosis and fractional flow reserve ≤0.8, or stenosis 50%-89% and fractional flow reserve\> 0.8. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Time frame: from the date of enrollment until the date of discharge, up to 30 days
Efficacy of MCG in early stratification of patients with suspected NSTE-ACS
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For early stratification measurement, patients with suspected NSTE-ACS are assessed by 30d (from enrollment) MACE and classified as high or low risk. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy of MCG.
Time frame: from the date of enrollment until the date of discharge, up to 30 days