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

A

AMCG

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Diagnostic Test: Rest MCG scan
Diagnostic Test: Rest/Stress MCG scan

Study type

Observational

Funder types

Industry

Identifiers

NCT05825911
AMCG-CT01

Details and patient eligibility

About

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

Full 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.

Enrollment

908 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

2

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Central trial contact

Hoseong Lee Deputy general manager

Data sourced from clinicaltrials.gov

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