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

Coronary Artery Disease Clinical Trial

— EDAM-CAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05825911
• Other study ID #: AMCG-CT01
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2023
• Source: AMCG
• Contact: Hoseong Lee Deputy general manager
• Phone: +82-02-598-8001
• Email: lhs[@]amcg.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 554
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Namdong-gu
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul	Eunpyeong-gu

Sponsors (1)

Lead Sponsor	Collaborator
AMCG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major adverse cardiac event after 30 days of CAG	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).	1 month
Other	Comparison of MCG scan with cardiac SPECT test	Comparison with cardiac SPECT test will be performed with statistical analysis including sensitivity and specificity.	1 day
Other	Comparison of sensitivity and specificity between stress MCG scan and stress ECG test	Comparison of sensitivity and specificity between stress MCG scan and stress ECG test	1 day
Primary	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	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