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

Last updated: July 29, 2024
Sponsor: AMCG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Thrombosis

Vascular Diseases

Treatment

Rest/Stress MCG scan

Rest MCG scan

Clinical Study ID

NCT05825911
AMCG-CT01
  • Ages 19-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over 19 years of age at the time of enrollment

  • Patient presenting for CAG

  • Consents to having an MCG scan study

Exclusion

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 Design

Total Participants: 908
Treatment Group(s): 2
Primary Treatment: Rest/Stress MCG scan
Phase:
Study Start date:
June 24, 2024
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

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

    Seoul, Eunpyeong-gu 03312
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu 21565
    Korea, Republic of

    Active - Recruiting

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