Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease

Myocardial Ischemia Clinical Trial

Official title:

Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170027
• Other study ID #: 999-03
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 14, 2011
• Start date: July 2003
• Est. completion date: July 2007

Study information

• Verified date: February 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Subjects with chest pain syndrome or angina equivalent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Magnetocardiograph

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	CardioMag Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint will be final clinical diagnosis of ischemia by the primary treating physician. This decision will be based upon evaluation of symptoms, clinical presentation, 12-lead ECG, cardiac enzymes (Troponin I or CKMB).
Secondary	1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography
Secondary	2. Correlation of MCG with functional and laboratory tests

External Links

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