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OpenTrials
Completed

NCT Number: NCT03358368

MCG Post Myocardial Infarction Study

The study is being performed to evaluate a new portable medical device, the Creavo Vitalscan Magnetocardiograph (Vitalscan) on patients who have had a confirmed myocardial infarction (heart attack) within the previous 12 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Warwickshire NHS Trust

Warwick, Warwickshire, CV34 5BW, United Kingdom

About this study

Magnetocardiography (MCG) is a non-contact, passive, imaging technique that detects the magnetic fields generated by the electrical activity of the heart. The MCG technology has been evaluated in several clinical studies, demonstrating its potential usefulness in the detection of patients with stable angina and acute coronary syndrome (ACS), including non-ST segment elevation myocardial infarction (NSTEMI).

Previous studies have been completed using earlier versions of the Vitalscan device. Results showed that the device could differentiate between patients with confirmed ischaemic heart disease (IHD) and NSTEMI, those with non-IHD experiencing chest pain and healthy (non-ischaemic) control subjects.

The aim of this pilot study is to assess the difference between abnormal MCG images from patients with a confirmed and recent myocardial infarction (MI)and normal images from previously obtained healthy volunteer controls scanned with the current device, so that comparisons can be made to the data acquired from the previous studies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with confirmed myocardial infarction within 12 weeks of the initial event
  • Patients admitted to the Coronary Care Unit (CCU) at Warwick Hospital on the point of discharge or patients already discharged from the CCU attending the cardiac rehabilitation classes
  • 18+ year old male or female
  • Patient is willing and able to give written informed consent

Exclusion criteria

  • Atrial fibrillation
  • Thoracic metal implants (cardiac stents allowed)
  • Pacemaker or internal defibrillator
  • Pregnancy (if after 20-week period)* or lactation
  • Patient unable to lie down (i.e. supine position up to a maximum 25 degree tilt) 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)
  • There should not be any effect on pregnancy due to the non-invasive nature of the device. Pregnancy after the 20-week period excluded from the study due to the size and position of the foetus and unknown possibility of picking up the foetal heartbeat, rendering the scan non-usable for study requirements

Treatment and study plan

Vitalscan

Device

Vitalscan is a magnetocardiograph device

Primary outcomes

  1. MCG parameter extraction

    Time frame: From baseline scan

    To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction

Secondary outcomes

  1. MCG parameter analysis

    Time frame: From baseline scan

    To use the markers identified to differentiate between abnormal (post MI) images and normal (healthy volunteer) images using evaluation performance measures

Sponsors and collaborators

Lead sponsor

Creavo Medical Technologies Ltd

Industry

Registry information

Official study title

A Prospective Single-centre Pilot Study to Assess a Magnetocardiograph Device in Patients Following Myocardial Infarction.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2017
Registry last updated
Dec 20, 2018

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.

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