Acute Coronary SyndromePRISM/PRISM2NCT06481943
A Prospective Research Investigation of Ischemia Using MCG
An observational study of Acute Coronary Syndrome, run by SB Technology, Inc. at 2 sites in United States.
Trial summary
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Sponsor MCG device (CardiAQ)
- Type of treatment
- Medical device
- How many people
- 335 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS).
Who may be able to join
- Scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction
- Ability for participant to comply with study requirements
- Patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities
- Written informed consent
Who cannot join
- Present STEMI
- Pregnant or breastfeeding
- Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- Active thoracic metal implant
- Poor access to follow-up
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Sajiny John, 631-750-6345, sajiny.john@mountsinai.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Ghasaq Saleh, MD, 5072552504, saleh.ghasaq@mayo.edu
Mohamad A Alkhouli, MD, MBA
About this study
Official title: A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Sponsor MCG device (CardiAQ)
- 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 device (CardiAQ)Device
Unshielded magnetocardiography device for measuring cardiac magnetic fields
| Study group | Role | What they receive |
|---|---|---|
| ACS | Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS). Patients are further classified as having low, medium, and high risk for ACS. Receives: Device: Sponsor MCG device (CardiAQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
Utilize linear regression and logistic regression to determine whether a set of a priori MCG-based biomarkers can prospectively predict the objective clinical assessment of ACS, while statistically adjusting for covariates.
Measured: Data taken within 24 hours of each other
Secondary outcomes (1)
Sponsor MCG device 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 Jul 2024
- Study start11 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Kit Yee Au-Yeung, PhD, Study director, SB Technology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481943
- Sponsor's protocol ID
- SB-ACS-003, SB-ACS-005
- Acronym
- PRISM/PRISM2
- Status last verified
- Oct 2025
- First submitted
- 25 Jun 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
- ClinicalTrials.gov ID
- NCT06481943
- Acronym / sponsor ID
- PRISM/PRISM2 / SB-ACS-003, SB-ACS-005
- Conditions
- Acute Coronary Syndrome
- Keywords
- Magnetocardiography, MCG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- SB Technology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Icahn School of Medicine at Mount Sinai
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Jul 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.
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS | – | Device: Sponsor MCG device (CardiAQ)Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS). Patients are further classified as having low, medium, and high risk for ACS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS).
Key inclusion criteria (4 listed)
- Scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction
- Ability for participant to comply with study requirements
- Patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities
- Written informed consent
Key exclusion criteria (5 listed)
- Present STEMI
- Pregnant or breastfeeding
- Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- Active thoracic metal implant
- Poor access to follow-up
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 device (CardiAQ)Unshielded magnetocardiography device for measuring cardiac magnetic fields | Device | ACS |
Primary outcome
Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
Time frame: Data taken within 24 hours of each other
Utilize linear regression and logistic regression to determine whether a set of a priori MCG-based biomarkers can prospectively predict the objective clinical assessment of ACS, while statistically adjusting for covariates.
1 secondary outcome
Sponsor MCG device safety
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Kit Yee Au-Yeung, PhD study director
SB Technology, Inc.
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 Acute Coronary Syndrome, run by SB Technology, Inc. at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie LeDang (408-981-8754, clinical-trials@sandboxquantum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between pre-procedural MCG and the peri-procedural angiography-based measures (time frame: Data taken within 24 hours of each other). 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 4 Sep 2026.