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NOT YET RECRUITING
NCT07078266

Comparative Study of Magnetocardiography and Emission Computed Tomography.

Sponsor: Yang Jing

View on ClinicalTrials.gov

Summary

Coronary atherosclerotic heart disease (CHD) and Coronary Microvascular Disease (CMVD), as the primary etiologies of myocardial ischemia, have garnered increasing clinical attention due to their high prevalence and severe prognostic implications. Currently, the primary method for detecting myocardial ischemia is Emission Computed Tomography (ECT). However, it suffers from limitations such as low spatial resolution and radiation exposure risks.magnetocardiography(MCG) is a non-invasive, contactless medical imaging device that maps localized magnetic signals generated by cardiac electrical activity.The magnetocardiography (MCG) system constructs cardiac magnetic field images by recording biomagnetic signals via a multi-channel sensor array positioned above the thoracic region.MCGcan capture the spatial magnetic field changes of ischemic myocardial cells, and carry out early warning, early diagnosis and positioning detection of myocardial ischemia. This study is a prospective, multicenter, controlled trial. The study will enroll adult patients presenting with myocardial ischemia symptoms suspected of having coronary heart disease (CHD) or coronary microvascular disease (CMVD), who are scheduled to undergo ECT examination.and a domestically manufactured "ultra-high sensitivity" cardiomagnetic detection device will be used to collect cardiac magnetic images. The ECT examination will be completed within one week. A consistency analysis will be conducted between the cardiac magnetic results and the ECT results to evaluate the early diagnostic efficacy of cardiac magnetic detection for myocardial ischemia. Subgroup analyses will also be performed based on resting and stress conditions. Primary study endpoints:Diagnostic Performance of MCG in Detecting Myocardial Ischemia: Positive Predictive Value, Specificity, and Sensitivity. Secondary study endpoint:Concordance and Discrepancies Between MCG and ECT in Diagnosing Myocardial Ischemia.

Official title: Multicenter Comparative Study on the Diagnostic Efficacy of "Ultra-high Sensitivity" Cardiomagnetic Detection and Myocardial Nucleoradiology Scanning for Early Diagnosis of Myocardial Ischemia.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

218

Start Date

2025-07

Completion Date

2026-07

Last Updated

2025-07-22

Healthy Volunteers

Not specified

Interventions

DEVICE

Magnetocardiography examination

Magnetocardiography (MCG) is a non-invasive, risk-free, and contactless technology that characterizes the local magnetic field signals generated by the electrical activity of the heart. the magnetic signals used in magnetocardiograms can pass through the body with almost no interference. Therefore, magnetocardiography theoretically offers more clinically useful information, with the advantages of being non-invasive, safe, and fast, enabling earlier and more accurate diagnoses of potential heart diseases.