NCT05825911

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 908 (estimated)
• Sponsor: AMCG · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Artery Disease

Interventions

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

Timeline

• Start date: 2024-06-24
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2023-04-24
• Last updated: 2024-07-31

Locations

2 sites across 1 country: South Korea