VitalScan MCG Rule-out Multi-centre Pivotal Study - UK

Launched by CREAVO MEDICAL TECHNOLOGIES LTD · Sep 29, 2016

Keywords

ClinConnect Summary

Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve c...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
• • 18+ year old male or female
• • Patient is willing and able to give written informed consent
• Exclusion Criteria:
• • ST-segment Elevation MI (STEMI)
• • Clear non-ischaemic cause for symptoms (e.g. trauma)
• • Haemodynamic instability on admission (e.g. BP\>220mmHg systolic \& \>110mmHg diastolic, \<80mmHg systolic \& \<40mmHg diastolic, HR\>160bpm)
• • Ventricular tachycardia or fibrillation that cannot be treated effectively
• • Atrial fibrillation
• • Thoracic metal implants
• • Pacemaker or internal defibrillator
• • Pregnancy (if after 20-week period)\* or lactation
• • Patient unable to lie down (i.e. supine position) 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)
• • Patient unable to comply with the requirements of the protocol