ACS - Acute Coronary SyndromeNCT06095557
MCG Discovery Study in Emergency Departments
A study testing Sponsor MCG device in people with ACS - Acute Coronary Syndrome and NSTEMI - Non-ST Segment Elevation MI, run by SB Technology, Inc. at 1 site in United States.
Trial summary
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS - Acute Coronary Syndrome, NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Sponsor MCG device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 8 Jul 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
- Can provide written consent
Who cannot join
- Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
- Presents to ED with Atrial Fibrillation
- Clear non-ischemic cause for symptoms (i.e. trauma)
- Active thoracic metal implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
- Being tested
- Sponsor MCG device
- Keywords
- magnetocardiography, MCG
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponsor MCG deviceDevice
unshielded device measuring cardiac magnetic fields
| Study group | Role | What they receive |
|---|---|---|
| Sponsor MCG device | Experimental | All participants will receive a scan from the Sponsor MCG device Receives: Device: Sponsor MCG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
% analyzable Sandbox MCG data
% Sandbox MCG data collected and suitable for analysis
Measured: during the procedure (MCG scan)
Secondary outcomes (4)
Sandbox MCG safety
Device-related adverse events
Measured: 30 days
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Signal Noise Ratio of ECG features
Measured: during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
t-wave field maximum angle
Measured: during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
heartbeats needed to obtain signal
Measured: during the procedure (MCG scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Oct 2023
- Primary completion9 Jun 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS - Acute Coronary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- SB Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kit Yee Au-Yeung, PhD, Study director, SB Technology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095557
- Sponsor's protocol ID
- SB-ACS-002
- Status last verified
- Oct 2025
- First submitted
- 12 Oct 2023
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
- ClinicalTrials.gov ID
- NCT06095557
- Acronym / sponsor ID
- SB-ACS-002
- Keywords
- magnetocardiography, MCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- SB Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 23 Oct 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 prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sponsor MCG device | Experimental | Device: Sponsor MCG deviceAll participants will receive a scan from the Sponsor MCG device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
- Can provide written consent
Key exclusion criteria (4 listed)
- Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
- Presents to ED with Atrial Fibrillation
- Clear non-ischemic cause for symptoms (i.e. trauma)
- Active thoracic metal implants
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 |
|---|---|---|
| Sponsor MCG deviceunshielded device measuring cardiac magnetic fields | Device | Sponsor MCG device |
Primary outcome
% analyzable Sandbox MCG data
Time frame: during the procedure (MCG scan)
% Sandbox MCG data collected and suitable for analysis
4 secondary outcomes
Sandbox MCG safety
Time frame: 30 days
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time frame: during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time frame: during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time frame: during the procedure (MCG scan)
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 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for ACS - Acute Coronary Syndrome
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
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.
Kit Yee Au-Yeung, PhD study director
SB Technology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sponsor MCG device in people with ACS - Acute Coronary Syndrome and NSTEMI - Non-ST Segment Elevation MI, run by SB Technology, Inc. at 1 site in United States.
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 2 inclusion and 4 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 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
% analyzable Sandbox MCG data (time frame: during the procedure (MCG scan)). 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 21 Oct 2025.