Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170027
Status:
COMPLETED
Last Update Posted:
2011-02-15
First Post:
2005-09-12
Brief Title:
Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A magnetocardiograph MCG is a medical device capable of recording the magnetic fields that arise from the electrical activity of the heart It was developed for the general purpose as a noninvasive non-contact diagnostic tool of obstructive coronary artery disease CAD and especially of cardiac ischemia The overall objective of the present study is to demonstrate the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart as in an Heart attack in patients presenting with chest pain
Detailed Description:
The CMI-2409 magnetocardiograph MCG is an FDA-approved medical device capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart This system was developed by CMI for the general purpose of noninvasive non-contact diagnostics of obstructive coronary artery disease CAD and especially of cardiac ischemia The overall objective of the present study is to demonstrate the efficacy of this MCG device and of the associated MCG method for the detection and diagnosis of ischemia in chest pain patients
The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology In this study the rest MCG data will be analyzed and compared to the results of a rest ECG
The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology In this study the rest MCG data will be analyzed and compared to the results of a rest ECG
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