Comparative Study of Magnetocardiography and Emission Computed Tomography.

NCT07078266 | Not Yet Recruiting

• 1 other identifier: 2025-28
• Study Type: observational
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myocardial Ischemia

Keywords

Coronary atherosclerotic Heart Disease; Coronary Microvascular Disease; Myocardial Ischemia; Magnetocardiograph; Emission Computed Tomography

Outcome Measures

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.

  2025.7-2026.7

Interventions

Magnetocardiography examination DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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;
• Patients with severe renal insufficiency with an estimated glomerular 6.filtration rate (eGFR) \< 30 ml/min or those undergoing dialysis;
• Patients with malignant tumors and a life - expectancy of less than1 year;
• Pregnant or lactating women;
• Patients unable to undergo MCG examination due to inability to enter the chamber, metallic implant interference, or other conditions deemed unsuitable by researchers.

Sponsors & Collaborators

• Yang Jing: lead
• Qilu Hospital of Shandong University: collaborator

MeSH Terms

Conditions

Myocardial Ischemia; Microvascular Angina

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris

Central Study Contacts

Jun Xiao PhD

CONTACT

+8613908340310; xj73wy@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-06