A Prospective Research Investigation of Ischemia Using MCG

NCT ID: NCT06481943

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-11

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Sponsor MCG device (CardiAQ)

Intervention Type DEVICE

Unshielded magnetocardiography device for measuring cardiac magnetic fields

Interventions

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Sponsor MCG device (CardiAQ)

Unshielded magnetocardiography device for measuring cardiac magnetic fields

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

SB Technology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kit Yee Au-Yeung, PhD

Role: STUDY_DIRECTOR

SB Technology, Inc.

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maggie LeDang

Role: CONTACT

408-981-8754

Facility Contacts

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Ghasaq Saleh, MD

Role: primary

5072552504

Sajiny John

Role: primary

631-750-6345

Other Identifiers

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SB-ACS-003, SB-ACS-005

Identifier Type: -

Identifier Source: org_study_id

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