A Study to Assess the Accuracy of Magnetocardiography (MCG) to Diagnose True Ischemia in Patients With Chest Pain in the ED

NCT05809648 | Enrolling By Invitation

• 1 other identifier: 20-001225
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the research is to see if patients that come to the Emergency Department with chest pain can be more accurately and more quickly diagnosed by magnetocardiography (MCG) to see if their chest pain is caused by coronary ischemia (reduced blood flow to the heart) in patients with normal or have non-specific changes on the ECG vs other causes by other reasons.

Conditions

Chest Pain; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  Our primary objective is to measure the diagnostic accuracy of the Mesuron Avalon-H90 MCG device to detect ACS (unstable angina, NSTEMI) in Emergency Department patients who present with acute chest pain when compared to the current goal standard.

  12 months

Secondary Outcomes (1)

• Real-time rule out of ACS

  12 months

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

Subjects presenting with chest pain to the Mayo Clinic Minnesota, Saint Mary's hospital emergency department (ED).

You may qualify if:

• Patients presenting to the ED with acute chest pain when an ACS is on the differential diagnosis.
• Patient willing and able to give informed consent.

You may not qualify if:

• ST elevation \> 1 mm on any two contiguous ECG leads.
• Hemodynamic instability (SBP \>220 or \<80, HR \>160).
• Pregnant patients.
• Incarcerated patients (FMC patients).
• Patients with a pacemaker or defibrillator.
• Metal implants in the body (that are not MRI safe).
• Patients that are unable to lie down in the MCG machine or stay still.
• Patients who are unable to understand the informed consent process (ex: non-English speakers without an available interpreter, cognitive delay).
• Patients without the capacity to provide written informed consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Hevesi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: March 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)