A Prospective Research Investigation of Ischemia Using MCG

NCT06481943 | Recruiting FDA Device

• 1 other identifier: SB-ACS-003, SB-ACS-005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

Magnetocardiography; MCG

Outcome Measures

Primary Outcomes (1)

• 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.

  Data taken within 24 hours of each other

Secondary Outcomes (1)

• Sponsor MCG device safety

  30 days

Study Arms (1)

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.

Device: Sponsor MCG device (CardiAQ)

Interventions

Sponsor MCG device (CardiAQ) DEVICE

Unshielded magnetocardiography device for measuring cardiac magnetic fields

ACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SB Technology, Inc.: lead
• Mayo Clinic: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Kit Yee Au-Yeung, PhD

  SB Technology, Inc.

  STUDY DIRECTOR

Central Study Contacts

Maggie LeDang

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 11, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (2)