Recruiting

Ischemia

Sponsor:

SB Technology, Inc.

Code:

NCT06481943

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sponsor MCG device (CardiAQ)

Study Details

Brief 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.

Conditions

Acute Coronary Syndrome

Study ID

NCT06481943

Start date

Jul 11, 2024

Status verified date

Oct, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

335 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Sponsor MCG device (CardiAQ)

Unshielded magnetocardiography device for measuring cardiac magnetic fields

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 ]

Central Contacts and Locations

Central contacts

Maggie LeDang

408-981-8754clinical-trials@sandboxquantum.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ghasaq Saleh, MD

5072552504saleh.ghasaq@mayo.edu

Principal Investigator:

Mohamad A Alkhouli, MD, MBA

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Sajiny John

631-750-6345sajiny.john@mountsinai.org

More Information

Sponsor

SB Technology, Inc.

Last update posted

Sep 4, 2026

Last verified

Oct, 2025

Keywords

  • Magnetocardiography
  • MCG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SB Technology, Inc. on 2026-09-04.