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

Acute Coronary Syndrome Clinical Trial

— MAGNET-ACS  

Official 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, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921438
• Other study ID #: CIP 003
• Status: Completed
• Start date: February 6, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2018
• Source: Creavo Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: February 28, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• VitalScan Magnetocardiograph
A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.

Locations

Country	Name	City	State
United Kingdom	Southmead Hospital, North Bristol NHS Trust	Bristol
United Kingdom	Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust	Leicester
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust	Nottingham
United Kingdom	Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Creavo Medical Technologies Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of MCG	Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm	at discharge, 3 months follow-up
Secondary	Proportion of adverse events and types		at discharge, 3 months follow-up
Secondary	All-cause mortality (divided into CV and non-CV causes) proportion		through 1 week and 3 months follow-up
Secondary	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
Secondary	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