Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809648
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-26
First Post:
2023-03-30
Brief Title:
A Study to Assess the Accuracy of Magnetocardiography MCG to Diagnose True Ischemia in Patients With Chest Pain in the ED
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Prospective Blinded Observational Study to Assess the Accuracy of Magnetocardiography MCG as a Tool for Diagnosing Acute Coronary Syndrome ACS in Emergency Department Patients Presenting With Acute Chest Pain
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCG
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None