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The study is being performed to evaluate a new portable medical device, the Creavo Vitalscan Magnetocardiograph (Vitalscan) on patients who have had a confirmed myocardial infarction (heart attack) within the previous 12 weeks.
Full description
Magnetocardiography (MCG) is a non-contact, passive, imaging technique that detects the magnetic fields generated by the electrical activity of the heart. The MCG technology has been evaluated in several clinical studies, demonstrating its potential usefulness in the detection of patients with stable angina and acute coronary syndrome (ACS), including non-ST segment elevation myocardial infarction (NSTEMI).
Previous studies have been completed using earlier versions of the Vitalscan device. Results showed that the device could differentiate between patients with confirmed ischaemic heart disease (IHD) and NSTEMI, those with non-IHD experiencing chest pain and healthy (non-ischaemic) control subjects.
The aim of this pilot study is to assess the difference between abnormal MCG images from patients with a confirmed and recent myocardial infarction (MI)and normal images from previously obtained healthy volunteer controls scanned with the current device, so that comparisons can be made to the data acquired from the previous studies.
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Exclusion criteria
Atrial fibrillation
Thoracic metal implants (cardiac stents allowed)
Pacemaker or internal defibrillator
Pregnancy (if after 20-week period)* or lactation
Patient unable to lie down (i.e. supine position up to a maximum 25 degree tilt) or stay still on the examination bed
Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English-speaking relative/translator not available)
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Data sourced from clinicaltrials.gov
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