Skip to main content
OpenTrials
Completed

NCT Number: NCT02921438

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southmead Hospital, North Bristol NHS Trust, Bristol, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VitalScan Magnetocardiograph

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of adverse events and types

    Time frame: at discharge, 3 months follow-up

  2. All-cause mortality (divided into CV and non-CV causes) proportion

    Time frame: through 1 week and 3 months follow-up

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Creavo Medical Technologies Ltd

Industry

Registry information

Official study 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.

Acronym: MAGNET-ACS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 3, 2016
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.