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

Stopped early

Conditions studied: Acute Coronary Syndrome

In brief

A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.

Key facts

Study ID

NCT03546933

Run by

Creavo Medical Technologies Ltd

People needed

651

Starts

2018-07-17

Expected to finish

2019-08-06

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• ST-segment Elevation MI (STEMI)
• Clear non-ischemic cause for symptoms (e.g. trauma)
• Hemodynamic 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

Where it is running

• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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