Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.

NCT00169975 | Completed

• 1 other identifier: 738-04
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 2. Compare the discriminatory ability of scores derived from the MCG, the troponin level, and the ECG results, separately or in combination, to discriminate between patients with without a diagnosis of ACS at discharge.

  1 year

Secondary Outcomes (1)

• 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.

  1 year

Interventions

Magnetocardiograph DEVICE

MCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\*ACC/AHA Guidelines for Unstable Angina: High Risk (≥1 of the following) History * Accelerating tempo of ischemic symptoms in the last 48 hrs Pain * Prolonged, ongoing (\>20 min) rest pain (resistant to treatment) Clinical findings * Pulmonary edema * New / ↑ MR murmur * S3 or new/ ↑ rales * Hypotension, brady -/tachycardia - Age\>75y ECG * Angina at rest with transient ST changes \>0.05 mV * New (L)BBB * Sustained VT Cardiac Markers * Markedly elevated troponin Patients classified as having high-risk unstable angina at presentation in the ED will be approached for enrollment in the study.

You may qualify if:

• Patients classified as having High Risk Unstable Angina according to the ACCIAHA guidelines.
• Age ≥ 18 years.

You may not qualify if:

• Hemodynamically unstable patients.
• Patients who just prior to or just after admission exhibit tachycardia with heart rates exceeding 150 bpm.
• Patients with third degree AV Block.
• Patients with pacemakers or internal cardiac defibrillators.
• Patients who cannot lie in a supine position for the MCG examination.
• Patients who refuse entry into the registry

Sponsors & Collaborators

• Mayo Clinic: lead
• CardioMag Imaging: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Peter A. Smars, M.D. EM

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

US (1)