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Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005
Sponsors and Collaborators: Mayo Clinic
CardioMag Imaging
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00169975
  Purpose

A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The overall objective of this study is to demonstrate the efficacy of this MCG device for the detection and diagnosis of lack of oxygen of the heart in patients with chest pain.


Condition Intervention Phase
Myocardial Ischemia
Device: Magnetocardiograph
Phase III

MedlinePlus related topics: Angina
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina as Defined by ACC/AHA Guidelines

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 1. Determine the discriminatory ability of the scores derived from the MCG evaluation to discriminate between patients with versus without a clinical diagnosis of ACS at discharge.
  • 2. Compare the discriminatory ability of scores derived from the MCG, the troponin level, and the ECG results, seperately or in combination, to discriminate between patients with without a diagnosis of ACS at discharge.

Secondary Outcome Measures:
  • 1. Evaluate the sensitivity of the MCG to detect an ultimate diagnosis of ACS, MI, CHF, or death at 1 month, 6 months, and 1 year following discharge.

Estimated Enrollment: 200
Study Start Date: August 2004
Detailed Description:

Coronary Artery Disease is the leading cause of death in the United States. The non invasive detection of Acute Coronary Syndromes (ACS's) remains a clinical challenge. Electrocardiogram (ECG) may only diagnose myocardial infarction in 50 % of the cases. Magnetocardiography is a new and noninvasive method capable of measuring and mapping the magnetic field that is generated during the cardiac cycle. The electric current is affected by ischemic damage, which in turn alters the magnetic field. The magnetic field is not affected by body tissues, unlike the surface current measurements in ECG.

Comparisons: The diagnostic accuracy of the CMI-Magnetocardiograph will be compared to that of the ECG in diagnosing High Risk Unstable Angina.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Patients classified as having Unstable Angina according to the ACC/AHA guidelines.

    High Risk (>= 1 of the following) History

    • Accelerating tempo of ischemic symptoms in the last 48-h. Pain
    • Prolonged, ongoing (>20 min) rest pain (resistant to treatment) Clinical finding
    • Pulmonary edema
    • New/ - MR murmur
    • S3 or new/ -rales
    • Hypotensive, brady-/tachy-cardia
    • Age > 75 years ECG
    • Angina at rest with transient ST changes > 0.05 mV
    • New LBBB
    • Sustained VT Cardiac Markers
    • Markedly elevated troponins
  2. Age >= 18 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169975

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

Study ID Numbers: 738-04
Study First Received: September 12, 2005
Last Updated: November 21, 2005
ClinicalTrials.gov Identifier: NCT00169975  
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Angina Pectoris
Pain
Ischemia
Angina, Unstable
Chest Pain

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009