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

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: VitalScan Magnetocardiograph

• Registration Number: NCT02921438
• Lead Sponsor: Creavo Medical Technologies Ltd

Brief Summary

The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.

Detailed Description

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 cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. \<\< 2% false negative rate) in patients presenting to an emergency setting with chest pain.

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2017-02-06
• Status Verified: 2018-12
• Primary Completion: 2018-12-14
• Study Completion: 2019-02-28
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chest pain patients presenting to the ED	VitalScan Magnetocardiograph	All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of MCG	at discharge, 3 months follow-up	Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm

Secondary Outcome Measures

Name	Time	Method
Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups	at discharge, 3 months follow-up
All-cause mortality (divided into CV and non-CV causes) proportion	through 1 week and 3 months follow-up
Proportion of adverse events and types	at discharge, 3 months follow-up
MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose])	through 1 week and 3 months

Trial Locations

Locations (5)

Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

St George's University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom

Southmead Hospital, North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom