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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Rest/Stress MCG scan; Diagnostic test: Rest MCG scan

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 Type: Observational
• Enrollment (Anticipated): 554

Contacts and Locations

• Study Contact: Name: Hoseong Lee Deputy general manager; Phone Number: +82-02-598-8001; Email: lhs@amcg.kr

Study Locations

• Korea, Republic of
  • Eunpyeong-gu
    • Seoul, Eunpyeong-gu, Korea, Republic of, 03312
      • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Contact: Sukmin Seo, MD, Ph.D
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
      • Contact: Kyounghoon Lee, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1. MAIN STUDY: This is an adult population at varying risk for CAD who will present at multicenter for cardiovascular screening with CAG.
2. SUB-STUDY: This is an normal adult population with age-, and sex-matched control group.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AMCG
• Investigators: Study Director: Hoseong Lee Deputy general manager, AMCG

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Magnetocardiography scan
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: AMCG-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No