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

Last updated: April 1, 2019
Sponsor: Creavo Medical Technologies Ltd
Overall Status: Completed

Phase

N/A

Condition

Angina

Heart Disease

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT02921438
CIP 003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 poorunderstanding of English (e.g. English-speaking relative/translator not available)

  • Patient unable to comply with the requirements of the protocol

Study Design

Total Participants: 756
Study Start date:
February 06, 2017
Estimated Completion Date:
February 28, 2019

Study 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.

Connect with a study center

  • Southmead Hospital, North Bristol NHS Trust

    Bristol,
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield, S5 7AU
    United Kingdom

    Site Not Available

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