VitalScan MCG Rule-out Multi-centre Pivotal Study - UK (MAGNET-ACS)

April 1, 2019 updated by: Creavo Medical Technologies Ltd

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

756

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • Southmead Hospital, North Bristol NHS Trust
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chest pain patients presenting to the ED
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of MCG
Time Frame: at discharge, 3 months follow-up
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 Outcome Measures

Outcome Measure
Time Frame
Proportion of adverse events and types
Time Frame: at discharge, 3 months follow-up
at discharge, 3 months follow-up
All-cause mortality (divided into CV and non-CV causes) proportion
Time Frame: through 1 week and 3 months follow-up
through 1 week and 3 months follow-up
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
Time Frame: at discharge, 3 months follow-up
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])
Time Frame: through 1 week and 3 months
through 1 week and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creavo Medical Technologies Ltd

Investigators

  • Principal Investigator: Steve Goodacre, MB ChB MRCP DiplMC FCEM, University of Sheffield; Sheffield, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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