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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05809648
Other study ID # 20-001225
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 17, 2023
Est. completion date March 2025

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Hypothesis: MCG can accurately, and in real-time, identify an acute coronary syndrome for patients presenting to the emergency department (ED) with chest pain and is faster than current practice. Aims, purpose, or objectives: 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. Our secondary objectives are as follows: - To study the ability of MCG to rule in or rule out ACS in real-time. We will assess the value of the MCG results in conjunction with the HEART pathway score. This will include looking at the diagnostic test accuracy, sensitivity and specificity of the device when used in conjunction with and without the HEART Pathway score, including versus excluding the troponin level (as the results of this is usually delayed by 45 minutes to 1 hour). In this way, we hope to demonstrate this technology may decrease ED length of stay in chest pain patients and decrease time to diagnosis. The comparison goal standard will be the Cardiology diagnosis, the result of serial troponins, or the ED diagnosis depending on the disposition of the patient. - To estimate ability of MCG for prognostication for major adverse cardiac events (MACE) at 3 days, 7 days, 30 days and 90 days.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Real-time rule out of ACS • To study the ability of MCG to rule in or rule out ACS in real-time. We will assess the value of the MCG results in conjunction with the HEART pathway score. This will include looking at the diagnostic test accuracy, sensitivity and specificity of the device when used in conjunction with and without the HEART Pathway score, including versus excluding the troponin level (as the results of this is usually delayed by 45 minutes to 1 hour). In this way, we hope to demonstrate this technology may decrease ED length of stay in chest pain patients and decrease time to diagnosis. The comparison goal standard will be the Cardiology diagnosis, the result of serial troponins, or the ED diagnosis depending on the disposition of the patient. 12 months
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