Chest PainNCT02359773
Magnetocardiography as a Tool for Patients Presenting With Chest Pain - Pilot Study
An observational study of Chest Pain, run by Quantum Imaging Limited at 1 site in United Kingdom.
Trial summary
The purpose of this pilot research study is to identify the characteristics of magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial infarction patient status. The study uses a non SQUID magnetocardiogram device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Aug 2015
- 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 presenting in Accident and Emergency Department with chest pain of presumed ischemic origin
Who may be able to join
- Non ischemic chest pain subject inclusion criteria
- Subjects will be males or females over the age of 18.
- Subjects will have experienced chest pain within the last 8 weeks and have been subsequently referred to the rapid access chest pain clinic (RACPC).
- Subjects will have no coronary artery disease/ischemia as demonstrated by one of the following: MRI, myoview or stress echo within no less than 4 weeks prior to the magnetocardiogram (MCG) scan.
- Subjects will have given written informed consent to participate in the study.
- Myocardial Infarction subject inclusion criteria
Show all 11Show fewer
- Subjects will be males or females over the age of 18.
- Subjects will have experienced chest pain and have been admitted to the cardiology unit.
- Subjects will have an abnormal level of Troponin (≥50ng/l) taken at 12 hours following the onset of chest pain.
- Subjects will be suitable to have an MCG scan taken within 48 hours of the onset of chest pain and prior to coronary angioplasty or any other surgical intervention.
- Subjects will have given written informed consent to participate in the study.
Who cannot join
- Non ischemic chest pain subject exclusion criteria
- Subjects with symptoms suggestive of acute coronary syndrome that require further investigation.
- Subjects who had an abnormal level of Troponin (≥50ng/l) - as determined by a test performed prior to referral to the RACPC.
- Subjects who have a pacemaker or internal cardiac defibrillator.
- Subjects with an active implantable device.
- Subjects with ferrous implants in the torso including wires or ferrous stents.
Show all 19Show fewer
- Subjects who are pregnant.
- Subjects who are unable to lie in a supine position.
- Subjects with any comorbidity that prevents them being scanned.
- Myocardial Infarction subject exclusion criteria
- Subjects who have had a STEMI.
- Patients with haemodynamic instability (dysrhythmia or hypotension).
- Subjects who have had a revascularisation technique performed prior to an MCG scan.
- Subjects who have a pacemaker or internal cardiac defibrillator.
- Subjects with ferrous implants in the torso including wires or ferrous stents.
- Subjects with an active implantable device.
- Subjects who are pregnant.
- Subjects who are unable to lie in a supine position.
- Subjects with any comorbidity that prevents them being scanned.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS2 9DF
About this study
Official title: Two Cohort, Pilot Study, to Identify Magnetocardiogram Characteristics That Can be Used to Classify Non Ischemic Chest Pain Patients and Myocardial Infarction Patients.
The purpose of this pilot research study is to identify the characteristics of magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial infarction patient status. The study uses a non SQUID magnetocardiogram device.
Read the detailed description
Magnetocardiography (MCG) is a passive, non-contact technique to measure the electromagnetic activity of the heart.
Heart muscle is controlled by electrical impulses that initiate contraction of the myocardium to pump blood around the body. A wave of depolarisation and repolarisation helps to coordinate the heart's activity which is usually measured using an electrocardiogram (ECG) which reflects the surface electrical manifestation of myocardial depolarisation and repolarisation
For every electrical signal there is a corresponding magnetic field, as defined by Faraday's law of induction, and it is this magnetic field that MCG measures.
There are two key advantages of looking at the magnetic field rather than the electrical signal. (1) The signal is not attenuated as it passes through the body, so information is not lost and (2) changes in the action potential (for example those caused by ischemia) are 'magnified' in the magnetic field so are easier to detect by sensors that are not in direct contact with the body.
SQUID MCG has been used widely in cardiology research, and previous clinical studies have shown that the technology has potential for the analysis of patients with coronary artery disease.
The aim of this pilot study is to identify characteristics of MCG that differentiate patients with non-ischaemic chest pain from those with a myocardial infarction.
.
- Conditions
- Chest Pain
- Keywords
- Magnetocardiography, Myocardial Infarction, Non-ischaemic chest pain
- Medical subject headings
- Chest Pain, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Non ischemic chest pain | No coronary artery disease (CAD) as confirmed by myoview, MRI or stress echo. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making. | |
| Group 2 - Myocardial infarction | Myocardial infarction confirmed by a troponin test (>50ng/l) 12 hours after the onset of chest pain. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetocardiogram Characteristics in patients with chest pain
Quantitative comparison of magnetocardiogram characteristics of non ischaemic chest pain patients compared to those with an acute myocardial infarction
Measured: 1 hour
Secondary outcomes (1)
Device Safety
Any adverse effects, adverse device effects, Unanticipated serious device effects
Measured: At time of scan for all patiients (Varies)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Imaging Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kearney, MBChB FRCP, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359773
- Sponsor's protocol ID
- QI CIP 001 Rev 001
- Status last verified
- Feb 2015
- First submitted
- 12 Jan 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Cohort, Pilot Study, to Identify Magnetocardiogram Characteristics That Can be Used to Classify Non Ischemic Chest Pain Patients and Myocardial Infarction Patients.
- ClinicalTrials.gov ID
- NCT02359773
- Acronym / sponsor ID
- QI CIP 001 Rev 001
- Conditions
- Chest Pain
- Keywords
- Magnetocardiography, Myocardial Infarction, Non-ischaemic chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Quantum Imaging LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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 purpose of this pilot research study is to identify the characteristics of magnetocardiograms that correlate with a non ischemic chest pain status and a myocardial infarction patient status. The study uses a non SQUID magnetocardiogram device.
Detailed description
Magnetocardiography (MCG) is a passive, non-contact technique to measure the electromagnetic activity of the heart.
Heart muscle is controlled by electrical impulses that initiate contraction of the myocardium to pump blood around the body. A wave of depolarisation and repolarisation helps to coordinate the heart's activity which is usually measured using an electrocardiogram (ECG) which reflects the surface electrical manifestation of myocardial depolarisation and repolarisation
For every electrical signal there is a corresponding magnetic field, as defined by Faraday's law of induction, and it is this magnetic field that MCG measures.
There are two key advantages of looking at the magnetic field rather than the electrical signal. (1) The signal is not attenuated as it passes through the body, so information is not lost and (2) changes in the action potential (for example those caused by ischemia) are 'magnified' in the magnetic field so are easier to detect by sensors that are not in direct contact with the body.
SQUID MCG has been used widely in cardiology research, and previous clinical studies have shown that the technology has potential for the analysis of patients with coronary artery disease.
The aim of this pilot study is to identify characteristics of MCG that differentiate patients with non-ischaemic chest pain from those with a myocardial infarction.
.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Non ischemic chest pain | – | –No coronary artery disease (CAD) as confirmed by myoview, MRI or stress echo. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making. |
| Group 2 - Myocardial infarction | – | –Myocardial infarction confirmed by a troponin test (>50ng/l) 12 hours after the onset of chest pain. Subjects will receive one MCG scan (intervention) using the QI Model 1.0 Magentocardiogram. This will be in addition to their current care and it will not be used to support clinical decision making. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting in Accident and Emergency Department with chest pain of presumed ischemic origin
Key inclusion criteria (11 listed)
- Non ischemic chest pain subject inclusion criteria
- Subjects will be males or females over the age of 18.
- Subjects will have experienced chest pain within the last 8 weeks and have been subsequently referred to the rapid access chest pain clinic (RACPC).
- Subjects will have no coronary artery disease/ischemia as demonstrated by one of the following: MRI, myoview or stress echo within no less than 4 weeks prior to the magnetocardiogram (MCG) scan.
- Subjects will have given written informed consent to participate in the study.
Key exclusion criteria (19 listed)
- Non ischemic chest pain subject exclusion criteria
- Subjects with symptoms suggestive of acute coronary syndrome that require further investigation.
- Subjects who had an abnormal level of Troponin (≥50ng/l) - as determined by a test performed prior to referral to the RACPC.
- Subjects who have a pacemaker or internal cardiac defibrillator.
- Subjects with an active implantable device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnetocardiogram Characteristics in patients with chest pain
Time frame: 1 hour
Quantitative comparison of magnetocardiogram characteristics of non ischaemic chest pain patients compared to those with an acute myocardial infarction
1 secondary outcome
Device Safety
Time frame: At time of scan for all patiients (Varies)
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 4 Aug 2015.
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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.
Mark Kearney, MBChB FRCP principal investigator
Leeds Teaching Hospitals NHS Trust
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 Chest Pain, run by Quantum Imaging Limited 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 11 inclusion and 19 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 4 Aug 2015. 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?
Magnetocardiogram Characteristics in patients with chest pain (time frame: 1 hour). 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 4 Aug 2015.