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NCT Number: NCT05825911

Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Eunpyeong-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rest/Stress MCG scan

Diagnostic Test

All patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG.

Rest MCG scan

Diagnostic Test

This is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan.

Primary outcomes

  1. Sensitivity and specificity of MCG scan

    Time frame: 1 day

    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.

Secondary outcomes

  1. Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan

    Time frame: 1 day

    Comparison with CAG will be performed for those having stress MCG scan test with statistical analysis including PPV, NPV, and diagnostic accuracy.

Other outcomes

  1. Major adverse cardiac event after 30 days of CAG

    Time frame: 1 month

    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).

  2. Comparison of MCG scan with cardiac SPECT test

    Time frame: 1 day

    Comparison with cardiac SPECT test will be performed with statistical analysis including sensitivity and specificity.

  3. Comparison of sensitivity and specificity between stress MCG scan and stress ECG test

    Time frame: 1 day

    Comparison of sensitivity and specificity between stress MCG scan and stress ECG test

Study contacts

Contact information is provided by the study sponsor or research team.

Hoseong Lee Deputy general manager

CONTACT

[email protected]

+82-02-598-8001

Sponsors and collaborators

Lead sponsor

AMCG

Industry

Registry information

Official study title

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

Acronym: EDAM-CAD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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