Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease - Full Text View

Sponsors and Collaborators:	Mayo Clinic CardioMag Imaging
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00170027

Purpose

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.

Condition	Intervention	Phase
Myocardial Ischemia	Device: Magnetocardiograph	Phase III

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 Outcome Measures:

1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography
2. Correlation of MCG with functional and laboratory tests

Estimated Enrollment:	250
Study Start Date:	July 2003
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Subjects with chest pain syndrome or angina equivalent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170027

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Reordan O De Jesus 507-255-9353 dejesus.reordan@mayo.edu
Principal Investigator: Peter A. Smars, M.D EM

Sponsors and Collaborators

Mayo Clinic

CardioMag Imaging

Investigators

Principal Investigator:

Peter A. Smars, M.D. EM

Mayo Clinic

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	999-03
Study First Received:	September 12, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00170027
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009