Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease

Study Overview
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Brief Summary
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This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.

Detailed Description
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This is multicenter, prospective, observational trial to evaluate the diagnostic accuracy of magnetocardiography(MCG) scan in detecting significant coronary artery disease(CAD) compared to the reference standard coronary arteriography(CAG). Chest pain patients scheduled for CAG will be offered to enroll in this clinical trial and provide informed consent to undergo with a rest/stress MCG scan prior to CAG. This MCG scan with a new 96 channel superconducting quantum interference device(SQUID) system is radiation-free, contactless and takes less than ten minutes to complete. Multiple studies have shown that the diagnostic accuracy of stress MCG scan is quite high in identifying patients with symptomatic CAD. Results will be interpreted and compared to the results of cardiac SPECT stress test, if available, and CAG. Participants will be followed up to 30 days via phone call or chart review. 30 day major adverse cardiac event(MACE) will be recorded and correlated with initial MCG scan results.

Official Title
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Evaluation of Diagnostic Accuracy of MCG Scan in Suspected Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Rest/Stress MCG scan
* Diagnostic Test: Rest MCG scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 19 years of age at the time of enrollment Patient presenting for CAG Consents to having an MCG scan study Exclusion Criteria: Patients unable to fit into MCG scan device Patients with implanted cardiac pacemakers/defibrillators Atrial fibrillation with rapid ventricular response Patients with other sustained or incessant arrhythmias Presence clinical suspicious of any acute coronary syndrome

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Rest/Stress MCG scan|All patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG.|
|Diagnostic Test: Rest MCG scan|This is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of MCG scan | Compare the diagnostic accuracy of stress MCG scan in detecting significant CAD compared to the current standard reference coronary angiogram(CAG) with statistical analysis including sensitivity, specificity. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan | Comparison with CAG will be performed for those having stress MCG scan test with statistical analysis including PPV, NPV, and diagnostic accuracy. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetocardiography scan, Coronary Artery Disease