Coronary Artery DiseaseEDAM-CADNCT05825911
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
An observational study of Coronary Artery Disease, run by AMCG at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rest/Stress MCG scan and Rest MCG scan
- How many people
- 600 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 24 Jun 2024to 30 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Over 19 years of age at the time of enrollment
- Patient presenting for CAG
- Consents to having an MCG scan study
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
South Korea2 sites
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312
About this study
Official title: Evaluation of Diagnostic Accuracy of MCG 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Rest/Stress MCG scan, Rest MCG scan
- Keywords
- Magnetocardiography scan, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest/Stress MCG scanDiagnostic test
All patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG.
Rest MCG scanDiagnostic test
This is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of MCG scan
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.
Measured: 1 day
Secondary outcomes (1)
Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan
Comparison with CAG will be performed for those having stress MCG scan test with statistical analysis including PPV, NPV, and diagnostic accuracy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start24 Jun 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- AMCG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoseong Lee Deputy general manager, Study director, AMCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825911
- Sponsor's protocol ID
- AMCG-CT01
- Acronym
- EDAM-CAD
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Accuracy of MCG Scan in Suspected Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05825911
- Acronym / sponsor ID
- EDAM-CAD / AMCG-CT01
- Conditions
- Coronary Artery Disease
- Keywords
- Magnetocardiography scan, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AMCGIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Over 19 years of age at the time of enrollment
- Patient presenting for CAG
- Consents to having an MCG scan study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rest/Stress MCG scanAll patients enrolled and receiving standard screening tests for CAD will undergo rest/stress MCG scan before CAG. | Diagnostic test | – |
| Rest MCG scanThis is an normal adult population with age-, and sex-matched control group. All participants enrolled will undergo rest MCG scan. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Positive predictive value(PPV), Negative predictive value(NPV), and diagnostic accuracy of MCG scan
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoseong Lee Deputy general manager study director
AMCG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by AMCG at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of MCG scan (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.