Clinical trial NCT05825911: Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
Official title: Evaluation of Diagnostic Accuracy of MCG Scan in Suspected Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Magnetocardiography scan
Coronary Artery Disease
Lead sponsor: AMCG
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 908
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. MAIN STUDY: This is an adult population at varying risk for CAD who will present at multicenter for cardiovascular screening with CAG.
2. SUB-STUDY: This is an normal adult population with age-, and sex-matched control group.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of MCG scan
timeFrame: 1 day
Secondary outcomes:
measure: Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan
timeFrame: 1 day
Other outcomes:
measure: Major adverse cardiac event after 30 days of CAG
timeFrame: 1 month
measure: Comparison of MCG scan with cardiac SPECT test
timeFrame: 1 day
measure: Comparison of sensitivity and specificity between stress MCG scan and stress ECG test
timeFrame: 1 day
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
state: Eunpyeong-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
affiliation: AMCG
name: Hoseong Lee Deputy general manager
role: STUDY_DIRECTOR
References: