MCG Device for Acute Coronary Syndrome

(DUET Trial)

Overseen By Maggie LeDang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SB Technology, Inc.

Disqualifiers: STEMI, Atrial fibrillation, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device designed to help doctors quickly and accurately assess heart issues in patients with elevated troponin levels. Troponin is a protein that appears in the blood when heart damage occurs. The trial will test the Sponsor MCG Device (also known as the SandboxAQ MCG device) in hospitals to determine if it can gather useful heart data for these patients. It seeks participants who have had a positive high-sensitivity troponin test result but do not have certain heart conditions, such as a STEMI heart attack, or are not experiencing atrial fibrillation (irregular heartbeat) at the time of the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for patients with elevated Troponin?

Research shows that magnetocardiography (MCG) devices, like the one being studied, have been used in other studies without major safety issues. These devices scan the heart to help detect heart problems. In a previous study, no serious side effects occurred when using MCG devices for heart scans. Hospitals can safely use them to collect heart data.

While this trial focuses on testing how well the device collects heart data, past research has not shown harmful effects from using similar devices. This trial is labeled "Not Applicable" for phase, indicating it aims to understand the device's effectiveness rather than test its safety. This suggests the device is considered safe enough for human trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MCG Device for Acute Coronary Syndrome because it offers a novel way to assess heart health using a non-invasive scan. Unlike traditional treatments that rely on medications or invasive procedures, this device uses advanced technology to provide real-time insights into cardiac function. This approach could potentially lead to faster and more accurate diagnosis, allowing for quicker intervention and better patient outcomes.

What evidence suggests that this device is effective for acute coronary syndrome?

Research has shown that magnetocardiography (MCG) holds promise for checking heart conditions. One study found that MCG detected heart issues with a sensitivity of 66.7% and a specificity of 57.1%, indicating it can fairly reliably identify heart problems. MCG is also consistent, as different doctors can obtain the same results using it. Another study suggested it can quickly identify serious coronary artery problems, aiding doctors in making faster decisions during emergencies. Overall, MCG could be a helpful tool for assessing heart issues, especially in patients with high troponin levels. In this trial, all participants will receive a scan from the sponsor's MCG device to evaluate its effectiveness in acute coronary syndrome. ^{6 7 8 9 10}

Who Is on the Research Team?

Kit Yee Au-Yeung, PhD

Principal Investigator

SB Technology, Inc.

Are You a Good Fit for This Trial?

This trial is for patients who have been diagnosed with Acute Coronary Syndrome and are currently in a hospital setting. They must have elevated Troponin levels, which indicate heart muscle damage.

Inclusion Criteria

Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)

Exclusion Criteria

Active thoracic metal implants

I currently have atrial fibrillation, confirmed by an ECG.

My symptoms are due to an injury, not poor blood flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a scan from the sponsor's MCG device to assess cardiac disease

1 day

1 visit (in-person)

Follow-up

Participants are monitored for device-related adverse events and data quality

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Sponsor MCG Device

Trial Overview The study is testing the use of a new Magnetocardiography (MCG) device by SandboxAQ to see if it can quickly and accurately measure heart disease in patients with high Troponin levels.

How Is the Trial Designed?

Group I: Sponsor MCG Device Experimental Treatment 1 Intervention

All participants will receive a scan from the sponsor's MCG device.

Who Is Running the Clinical Trial?

SB Technology, Inc.

Lead Sponsor

Trials

3

Recruited

290+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666602224000156

Accelerated magnetocardiography in the evaluation of ... MCG has high interrater reliability and demonstrates faster TTT and improved patient satisfaction. Further research should evaluate more in-depth comparison ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04044391?term=cardioflux&checkSpell=&rank=9

Use of Magnetocardiography in Evaluation of Patients ... This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery ...

3. clinconnect.io clinconnect.io/trials/NCT06620744

Magnetocardiography (MCG) Device Use in Patients With 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584647/

and long-term adverse outcomes following discharge in a ... We sought to create contemporary risk-prediction models for clinical outcomes following ACS up to 1 year following discharge.

5. researchgate.net researchgate.net/publication/378620776_Accelerated_magnetocardiography_in_the_evaluation_of_patients_with_suspected_cardiac_ischemia_The_MAGNETO_trial

Accelerated magnetocardiography in the evaluation of ... MCG sensitivity was 66.7 % (50.5–80.4 %, 95 % CI) and specificity 57.1 % (50.0–63.3 %, 95 % CI) for detecting coronary ischemia. Noninvasive stress testing ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10994860/

Accelerated magnetocardiography in the evaluation of ... MCGs were read independently by 3 physicians blinded to clinical data. Myocardial ischemia was ≥70 % epicardial coronary artery stenosis, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05825911

NCT05825911 | Evaluation of Diagnostic Accuracy of MCG ... This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.

8. trialx.com trialx.com/clinical-trials/listings/323159/a-prospective-research-investigation-of-ischemia-using-mcg/

A Prospective Research Investigation of Ischemia Using ... PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside ...

9. patlynk.com patlynk.com/trial/NCT06481943

A Prospective Research Investigation of Ischemia Using ... PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02921438

VitalScan MCG Rule-out Multi-centre Pivotal Study - UK The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) ...