MCG Post Myocardial Infarction Study

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358368
• Other study ID #: CIP 004
• Status: Completed
• Start date: March 22, 2018
• Est. completion date: August 10, 2018

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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 10, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Vitalscan
Vitalscan is a magnetocardiograph device

Locations

Country	Name	City	State
United Kingdom	South Warwickshire NHS Trust	Warwick	Warwickshire

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	MCG parameter extraction	To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction	From baseline scan
Secondary	MCG parameter analysis	To use the markers identified to differentiate between abnormal (post MI) images and normal (healthy volunteer) images using evaluation performance measures	From baseline scan