Clinical trial NCT00169975: Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CardioMag Imaging
First posted: 2005-09-15
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 criteria: Inclusion criteria:

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

Exclusion criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter A. Smars, M.D. EM
role: PRINCIPAL_INVESTIGATOR
References: