Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT05825911
- Lead Sponsor
- AMCG
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 908
- Over 19 years of age at the time of enrollment
- Patient presenting for CAG
- Consents to having an MCG scan study
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (2)
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Eunpyeong-gu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of