ACS - Acute Coronary SyndromeDUETNCT06620744
Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
A study testing Sponsor MCG deivce in people with ACS - Acute Coronary Syndrome, run by SB Technology, Inc. at 1 site in United States.
Trial summary
This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS - Acute Coronary Syndrome
- What is being tested?
- Sponsor MCG deivce
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2024to 15 Apr 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
- Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)
Who cannot join
- Present STEMI
- Having an active atrial fibrillation episode as seen on 12-lead ECG
- Clear non-ischemic cause for symptoms (e.g. 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, 10019
About this study
This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.
- Conditions
- ACS - Acute Coronary Syndrome
- Being tested
- Sponsor MCG deivce
- Keywords
- magnetocardiography, MCG
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponsor MCG deivceDevice
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's MCG device. Receives: Device: Sponsor MCG deivce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.
MCG Data Quality
Measured: Per-scan, on average 5 minutes, day of enrollment
Secondary outcomes (1)
Sandbox MCG safety
Device-related adverse events
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Sep 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06620744
- Sponsor's protocol ID
- SB-ACS-004
- Acronym
- DUET
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 5 Jun 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
- ClinicalTrials.gov ID
- NCT06620744
- Acronym / sponsor ID
- DUET / SB-ACS-004
- Conditions
- ACS - Acute Coronary Syndrome
- Keywords
- magnetocardiography, MCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SB Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 1 Oct 2024 (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 device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.
Study design
- Primary purpose
- Basic science
- 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 deivceAll participants will receive a scan from the sponsor's MCG device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)
Key exclusion criteria (4 listed)
- Present STEMI
- Having an active atrial fibrillation episode as seen on 12-lead ECG
- Clear non-ischemic cause for symptoms (e.g. 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 deivceUnshielded device measuring cardiac magnetic fields. | Device | Sponsor MCG Device |
Primary outcome
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.
Time frame: Per-scan, on average 5 minutes, day of enrollment
MCG Data Quality
1 secondary outcome
Sandbox MCG safety
Time frame: 30-days
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 5 Jun 2025.
- 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.
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 deivce in people with ACS - Acute Coronary Syndrome, 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 1 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 5 Jun 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?
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis. (time frame: Per-scan, on average 5 minutes, day of enrollment). 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 5 Jun 2025.