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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-24

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rest/Stress MCG scan

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes