Myocardial InfarctionNCT03358368
MCG Post Myocardial Infarction Study
An observational study of Myocardial Infarction, run by Creavo Medical Technologies Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Vitalscan
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2018to 10 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a confirmed myocardial infarction within 12 weeks of the initial event under the care of South Warwickshire NHS Foundation Trust.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Warwickshire NHS Trust
Warwick, Warwickshire, CV34 5BW
About this study
Official title: A Prospective Single-centre Pilot Study to Assess a Magnetocardiograph Device in Patients Following Myocardial Infarction.
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.
Read the detailed 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.
- Conditions
- Myocardial Infarction
- Being tested
- Vitalscan
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalscanDevice
Vitalscan is a magnetocardiograph device
What is being measured
The primary outcome is the main question the study is designed to answer.
MCG parameter extraction
To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction
Measured: From baseline scan
Secondary outcomes (1)
MCG parameter analysis
To use the markers identified to differentiate between abnormal (post MI) images and normal (healthy volunteer) images using evaluation performance measures
Measured: From baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start22 Mar 2018
- Primary completion27 Jun 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creavo Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Beadle, MBBS, Principal investigator, South Warwickshire NHS Foundation Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358368
- Sponsor's protocol ID
- CIP 004
- Status last verified
- Dec 2018
- First submitted
- 26 Nov 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-centre Pilot Study to Assess a Magnetocardiograph Device in Patients Following Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT03358368
- Acronym / sponsor ID
- CIP 004
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Creavo Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a confirmed myocardial infarction within 12 weeks of the initial event under the care of South Warwickshire NHS Foundation Trust.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitalscanVitalscan is a magnetocardiograph device | Device | – |
Primary outcome
MCG parameter extraction
Time frame: From baseline scan
To extract parameters from MCG scans to identify key characteristics (markers) for myocardial infarction
1 secondary outcome
MCG parameter analysis
Time frame: From baseline scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Beadle, MBBS principal investigator
South Warwickshire NHS Foundation Trust, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Creavo Medical Technologies Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCG parameter extraction (time frame: From baseline scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.