Comparative Study of Magnetocardiography and Emission Computed Tomography.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYang Jing

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years

Presence of myocardial ischemia-related symptoms (e.g., angina pectoris) with suspected CHD or CMVD, scheduled for ECT examination

Signed informed consent form

Disqualifiers

Hemodynamic instability (systolic blood pressure <90 mmHg or requiring vasoactive drugs);

Cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, severe sinus bradycardia and sinus pauses, and second - degree or higher - degree atrioventricular block and other severe arrhythmias;

Aortic dissection aneurysm, severe aortic valve stenosis or insufficiency;

Elderly or frail patients with neuromuscular or osteoarticular diseases who cannot complete exercise stress ECT; Allergy to drugs used in pharmacologic stress ECT;

Trial design

Treatments tested in this trial

  • Magnetocardiography examination

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Yang Jing

Lead sponsor

Chongqing Emergency Medical Center

Sponsor institution

Qilu Hospital of Shandong University

Collaborator