Comparative Study of Magnetocardiography and Emission Computed Tomography.
ConditionMyocardial Ischemia
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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Magnetocardiography examination
DeviceMagnetocardiography (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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluation Indicators: Diagnostic concordance between " ultra-high sensitivity" magnetocardiography (MCG) and rest/stress ECT (including exercise and pharmacological stress protocols) for detecting myocardial ischemia.
Time frame
2025.7-2026.7Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yang Jing
Lead sponsor
Chongqing Emergency Medical Center
Sponsor institution
Qilu Hospital of Shandong University
Collaborator
Source ClinicalTrials.gov
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