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

AMCG908 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

908

Conditions

Coronary Artery Disease

Interventions

Rest/Stress MCG scanDIAGNOSTIC_TEST

All patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG.

Rest MCG scanDIAGNOSTIC_TEST

This is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 1 day

Central Contacts

Hoseong Lee Deputy general manager

CONTACT

+82-02-598-8001 lhs@amcg.kr

Data from ClinicalTrials.gov

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