MCG Post Myocardial Infarction Study
A Prospective Single-centre Pilot Study to Assess a Magnetocardiograph Device in Patients Following Myocardial Infarction.
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2018
CompletedDecember 20, 2018
December 1, 2018
3 months
November 26, 2017
December 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
MCG parameter extraction
To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction
From baseline scan
Secondary Outcomes (1)
MCG parameter analysis
From baseline scan
Interventions
Vitalscan is a magnetocardiograph device
Eligibility Criteria
Patients who have had a confirmed myocardial infarction within 12 weeks of the initial event under the care of South Warwickshire NHS Foundation Trust.
You may qualify if:
- 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
- + year old male or female
- Patient is willing and able to give written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Warwickshire NHS Trust
Warwick, Warwickshire, CV34 5BW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Beadle, MBBS
South Warwickshire NHS Foundation Trust, UK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2017
First Posted
November 30, 2017
Study Start
March 22, 2018
Primary Completion
June 27, 2018
Study Completion
August 10, 2018
Last Updated
December 20, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share