VitalScan MCG rule-out multi-centre pivotal study - version 1.0
Research type
Research Study
Full title
A prospective multi-centre observational study to evaluate the diagnostic accuracy of a portable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, for patients who present to the emergency department with chest pain symptoms consistent with ACS.
IRAS ID
211679
Contact name
Steve Goodacre
Contact email
Sponsor organisation
Creavo Medical Technologies
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
The study is being performed to evaluate a new portable medical device for the Emergency Department (ED), the Creavo VitalScan Magnetocardiograph (VitalScan). The device may help doctors identify chest pain patients that are not having a heart attack or angina (acute coronary syndrome [ACS]), i.e. ruled-out, even though they arrive at the ED with symptoms consistent with ACS.
Although the existing tests for detecting a heart attack are very good, the current methods for identifying a chest pain patient that is not having a heart attack are not as good. Today, most chest pain patients have to stay in the ED for at least 4-6 hours, having blood drawn for a specific test multiple times, before they can be discharged home relatively safely. However, with current diagnostic tests, there is still about a 2% chance that the patient will be discharged home while having a heart attack.
VitalScan is a CE-marked device, indicating it is considered to be safe and effective. It is a passive, non-contact imaging device that detects the magnetic field produced by heart activity. It uses induction coils to produce an image of the magnetic field around the heart. It has been shown that the magnetic fields of people who are having a heart attack are different from those who are not.
The objective of the study is to evaluate the performance of VitalScan to safely and quickly rule-out ACS in chest pain patients who arrive at the ED with symptoms consistent with ACS. The study will enrol 756 subjects at 4 UK clinical sites over a 7-month period. Each subject will then be followed-up for 3 months to assess if any major adverse cardiac events have occurred during that time.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0454
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion