Acute Coronary SyndromeMAGNET-ACSNCT02921438
VitalScan MCG Rule-out Multi-centre Pivotal Study - UK
An observational study of Acute Coronary Syndrome, run by Creavo Medical Technologies Ltd at 5 sites in United Kingdom.
Trial summary
The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- VitalScan Magnetocardiograph
- Type of treatment
- Medical device
- How many people
- 756 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 6 Feb 2017to 28 Feb 2019
- 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: All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm
Who may be able to join
- Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
- 18+ year old male or female
- Patient is willing and able to give written informed consent
Who cannot join
- ST-segment Elevation MI (STEMI)
- Clear non-ischaemic cause for symptoms (e.g. trauma)
- Haemodynamic instability on admission (e.g. BP>220mmHg systolic \& >110mmHg diastolic, <80mmHg systolic \& <40mmHg diastolic, HR>160bpm)
- Ventricular tachycardia or fibrillation that cannot be treated effectively
- Atrial fibrillation
- Thoracic metal implants
Show all 11Show fewer
- Pacemaker or internal defibrillator
- Pregnancy (if after 20-week period)* or lactation
- Patient unable to lie down (i.e. supine position) 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)
- Patient unable to comply with the requirements of the protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Southmead Hospital, North Bristol NHS Trust
Bristol
Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust
Nottingham, NG7 2UH
Northern General Hospital
Sheffield, S5 7AU
About this study
Official title: A Prospective Multi-centre Observational Study to Evaluate the Diagnostic Accuracy of a Portable Magnetocardiograph Device for Acute Coronary Syndrome (ACS), Focusing on Rule-out Capability, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS.
The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.
Read the detailed description
Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. << 2% false negative rate) in patients presenting to an emergency setting with chest pain.
- Conditions
- Acute Coronary Syndrome
- Being tested
- VitalScan Magnetocardiograph
- Keywords
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, NSTE ACS, NSTEMI, Unstable Angina Pectoris, Coronary Artery Disease
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalScan MagnetocardiographDevice
A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.
| Study group | Role | What they receive |
|---|---|---|
| Chest pain patients presenting to the ED | All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph. Receives: Device: VitalScan Magnetocardiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of MCG
Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm
Measured: at discharge, 3 months follow-up
Secondary outcomes (4)
Proportion of adverse events and types
Measured: at discharge, 3 months follow-up
All-cause mortality (divided into CV and non-CV causes) proportion
Measured: through 1 week and 3 months follow-up
Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups
Measured: at discharge, 3 months follow-up
MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose])
Measured: through 1 week and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start6 Feb 2017
- Primary completion14 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creavo Medical Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Goodacre, MB ChB MRCP DiplMC FCEM, Principal investigator, University of Sheffield; Sheffield, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921438
- Sponsor's protocol ID
- CIP 003
- Acronym
- MAGNET-ACS
- Status last verified
- Dec 2018
- First submitted
- 29 Sep 2016
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre Observational Study to Evaluate the Diagnostic Accuracy of a Portable Magnetocardiograph Device for Acute Coronary Syndrome (ACS), Focusing on Rule-out Capability, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS.
- ClinicalTrials.gov ID
- NCT02921438
- Acronym / sponsor ID
- MAGNET-ACS / CIP 003
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, NSTE ACS, NSTEMI, Unstable Angina Pectoris, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Creavo Medical Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 3 Oct 2016 (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 study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.
Detailed description
Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. << 2% false negative rate) in patients presenting to an emergency setting with chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest pain patients presenting to the ED | – | Device: VitalScan MagnetocardiographAll patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm
Key inclusion criteria (3 listed)
- Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
- 18+ year old male or female
- Patient is willing and able to give written informed consent
Key exclusion criteria (11 listed)
- ST-segment Elevation MI (STEMI)
- Clear non-ischaemic cause for symptoms (e.g. trauma)
- Haemodynamic instability on admission (e.g. BP>220mmHg systolic \& >110mmHg diastolic, <80mmHg systolic \& <40mmHg diastolic, HR>160bpm)
- Ventricular tachycardia or fibrillation that cannot be treated effectively
- Atrial fibrillation
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 |
|---|---|---|
| VitalScan MagnetocardiographA passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside. | Device | Chest pain patients presenting to the ED |
Primary outcome
Sensitivity and specificity of MCG
Time frame: at discharge, 3 months follow-up
Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm
4 secondary outcomes
Proportion of adverse events and types
Time frame: at discharge, 3 months follow-up
All-cause mortality (divided into CV and non-CV causes) proportion
Time frame: through 1 week and 3 months follow-up
Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups
Time frame: at discharge, 3 months follow-up
MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose])
Time frame: through 1 week and 3 months
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 3 Apr 2019.
- Individual participant dataSharing planned: No
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Acute Coronary Syndrome
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.
Steve Goodacre, MB ChB MRCP DiplMC FCEM principal investigator
University of Sheffield; Sheffield, UK
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Creavo Medical Technologies Ltd at 5 sites 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 3 inclusion and 11 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Sensitivity and specificity of MCG (time frame: at discharge, 3 months follow-up). 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 3 Apr 2019.