EDAM-CAD: Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
Study Details
Study Description
Brief Summary
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of MCG scan [1 day]
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.
Secondary Outcome Measures
- Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan [1 day]
Comparison with CAG will be performed for those having stress MCG scan test with statistical analysis including PPV, NPV, and diagnostic accuracy.
Other Outcome Measures
- Major adverse cardiac event after 30 days of CAG [1 month]
The frequency and percentage of MACE collected 30 days after the end of the CAG and the types of events are presented. At this time, major adverse cardiovascular events (MACEs) to be collected include death due to cardiovascular disease (CV Death), myocardial infarction (Nonfatal MI), and ischemic cardiovascular events (Ischemic CV events).
- Comparison of MCG scan with cardiac SPECT test [1 day]
Comparison with cardiac SPECT test will be performed with statistical analysis including sensitivity and specificity.
- Comparison of sensitivity and specificity between stress MCG scan and stress ECG test [1 day]
Comparison of sensitivity and specificity between stress MCG scan and stress ECG test
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 19 years of age at the time of enrollment
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Patient presenting for CAG
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Consents to having an MCG scan study
Exclusion Criteria:
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Patients unable to fit into MCG scan device
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Patients with implanted cardiac pacemakers/defibrillators
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Atrial fibrillation with rapid ventricular response
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Patients with other sustained or incessant arrhythmias
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Presence clinical suspicious of any acute coronary syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | Eunpyeong-gu | Korea, Republic of | 03312 |
| 2 | Gachon University Gil Medical Center | Incheon | Namdong-gu | Korea, Republic of | 21565 |
Sponsors and Collaborators
- AMCG
Investigators
- Study Director: Hoseong Lee Deputy general manager, AMCG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMCG-CT01