Coronary Artery DiseaseMAAPNCT03635801
The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial
An observational study of Coronary Artery Disease and Diastolic Dysfunction, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
Purpose of this clinical investigation: clinical evaluation/accuracy of HeartSciences MyoVista High-Sensitivity (hsECG) 12 lead Electrocardiogram device, for patients presenting with cardiac related chest pain and/or Non ST-segment Elevation Myocardial Infarction (NSTEMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diastolic Dysfunction
- What is being tested?
- MyoVista 12 lead Electrocardiogram (ECG)
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 16 Nov 2023
- 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: Non ST segment Myocardial Infarction (NSTEMI)
Who may be able to join
- Prerequisites for inclusion to the clinical investigation will include:
- Signed informed consent prior to any procedure relating to the investigation
- Patient compliance with the clinical investigational plan
- Follow-up appointment(s) attendance
- Patient(s) presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
- Notable Electrocardiogram morphological changes, consistent with Myocardial Ischaemia (MI) i.e. T-wave inversion, Biphasic T-wave, ST-segment depression
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- Symptom onset of <12 hrs
- Elevated High Sensitivity Troponin Score
- GRACE score of >140
Who cannot join
- Have a recent documented Myocardial Infarction within 40 days prior to enrolment and commencement of this investigation
- Have had a recent Trans-Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) within 3 months prior to enrolment and commencement of this investigation
- Have undergone cardiac surgery or coronary revascularisation within 3 months prior to enrolment and commencement of this investigation
- Be less than 18 years of age
- Involvement of vulnerable subjects (e.g. those lacking capacity to provide informed consent)
- Be pregnant or planning to become pregnant at commencement of this investigation
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- Participation in another clinical investigational study. Justification for which is two fold - firstly, a conflict of interest between two clinical trials, and patient compliance. Use of drugs that may be contraindicated and alter the patient care pathway compromising the trial
- Have not provided a patient information sheet or patient consent form
- Any contraindication(s) to PCI
- Cardiogenic shock
- Awaiting Coronary Artery Bypass Grafting (CABG)
- Haemodynamic instability
- Recurrent Ventricular Tachycardia
- Recurrent Ventricular Fibrillation
- Atrial/Ventricular Septal defects (ASD's/VSD's)
- Those patients presenting with suspected N-STEMI and who are subsequently enrolled yet are deemed to have non-cardiac related chest pain post cardiological review will be discharged from the study and will therefore meet exclusion criteria. Neither further action nor participation will be expected
- N.B. In the event a patient is unable to make the decision to participate in the clinical investigation, i.e. lacking capacity to provide informed consent, then exclusion criteria will thus apply to such patients. For the purpose of this clinical trial, it is deemed that there will be no clinical benefit to either the patient nor the clinical investigation should inclusion of this cohort of patients be included and will be contrary to their quality of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention - The MAAP Trial
Purpose of this clinical investigation: clinical evaluation/accuracy of HeartSciences MyoVista High-Sensitivity (hsECG) 12 lead Electrocardiogram device, for patients presenting with cardiac related chest pain and/or Non ST-segment Elevation Myocardial Infarction (NSTEMI). To assess the early intervention of N-STEMI patients. Determine if clinical outcomes can be improved. Assessment will be made on the MYOVISTA's indices, numerical values, and sensitivity/specificity for early detection of cardiac dysfunction/disease,i.e. Coronary Artery Disease (CAD). Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigation/procedure by way of angiography, thus improving the patient care pathway. Recruitment will take place at the Royal Cornwall Hospitals Trust, the Sponsor who will fund the research. A single centre study. Participants will undergo a 12 lead MyoVista ECG in addition to a standard 12 lead ECG. This is not an invasive procedure and carries no risk to the patient. There will be no change in the patient care pathway. The study will last c. 2 years, enrolment of patients ceasing once the statistically significant number to power the study has been met which is sufficient and ethical. Prerequisites for inclusion to the clinical investigation include:
- Signed informed consent prior to any procedure relating to the investigation
- Patient compliance with the clinical investigational plan
- Follow-up appointment(s) attendance
- Patient(s) presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
- Notable Electrocardiogram morphological changes, consistent with Myocardial Ischaemia (MI) i.e. T-wave inversion, Biphasic T-wave, ST-segment depression
- Symptom onset of <12 hrs
- Elevated High Sensitivity Troponin Score
- GRACE score of >140 It is hoped that > 75% of patients seen will show willingness and compliance throughout the duration of the clinical investigation. Clinical benefits, early diagnosis of heart disease, streamlined triage of patients, reduction in morbidity/mortality, reduction in costs to National Health Service (NHS) and improved patient centered care.
Read the detailed description
The purpose of this clinical investigation is the clinical evaluation and accuracy of HeartSciences MyoVista High-Sensitivity (hsECG) 12 lead Electrocardiogram devices, for patients presenting with cardiac chest pain and/or Non ST-segment Elevation Myocardial Infarction (NSTEMI). To assess the early intervention of N-STEMI patients and determine if clinical outcomes can be improved. In addition, assessment will be made on the MYOVISTA's indices, numerical values, and sensitivity/specificity for early detection of cardiac dysfunction/disease, namely Coronary Artery Disease (CAD). The Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigation/procedure by way of angiography, thus improving the patient care pathway. This clinical investigation will answer an important clinical question, i.e. can outcomes in 'high-risk' N-STEMI patients be improved with the intervention of MyoVista 12 lead Electrocardiogram in the detection of heart disease/diastolic dysfunction, compared to current standard practice?This clinical investigation anticipates that outcomes are improved in 'high-risk' patients when early detection and diagnosis is made using the MyoVista. The clinical investigation should therefore determine whether there is a need for a change in patient management, specifically those patients presenting as N-STEMI. This will allow for earliest intervention, with the results and data of this clinical investigation informing National/International guidelines, practice and healthcare service provision. The Primary endpoint will be the acute reperfusion/revascularization of target coronary vessels by way of Percutaneous Coronary Intervention (PCI) with specified follow-up at six (6) and twelve (12) months, with twelve (12) month being the specified termination of the clinical investigation plan.This clinical investigation is a prospective, single-centred Pilot study. The total investigation duration is expected to be approximately 2 - 3 years.
- Conditions
- Coronary Artery Disease, Diastolic Dysfunction
- Being tested
- MyoVista 12 lead Electrocardiogram (ECG)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoVista 12 lead Electrocardiogram (ECG)Device
MyoVista 12 Lead Electrocardiogram (ECG)
| Study group | Role | What they receive |
|---|---|---|
| MyoVista 12 Lead (ECG) NSTEMI | Patients enrolling in this clinical investigation will undergo a standard 12-lead ECG using the MyoVista 12-lead hs ECG device. An ECG is a quick, safe and painless test. No electricity is put into the body while it's carried out.
There may be some slight discomfort when the electrodes are removed from the skin - similar to removing a sticking plaster - and some people may develop a mild rash where the electrodes were attached.
An ECG is performed under controlled conditions. Receives: Device: MyoVista 12 lead Electrocardiogram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MAAP Trial
The primary outcome is one that the MyoVista is a good predictor of the need for an Angiogram in those patients presenting with cardiac related chest pain, more specifically, NSTEMI patients. The Primary objective is to ascertain the efficacy of the MyoVista and evaluate its usefulness in expediting those patients that require further investigation/procedure by way of angiography/angioplasty, thus improving the patient care pathway.
Measured: Two Years
Secondary outcomes (1)
The MAAP Trial
The Secondary objective: To assess left ventricular function and ejection fraction, quality of life of patients, post procedure at 24 hours to asses any immediate benefit and with specified follow-up at six (6) and twelve (12) months, with twelve (12) month being the specified termination of the clinical investigation plan.
Echocardiography, High Sensitivity Cardiac Troponin, CKD (Chronic Kidney Disease) cardiac markers will feature as further diagnostic tools in addition to the MyoVista and Angiography supporting in this clinical investigation. Assessment on significant improvement in left ventricular systolic function, ejection fraction, exercise tolerance and quality of life will be made at Six (6) and Twelve (12) months post procedure
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2019
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Why it stopped: Due to PI's unavailability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandros Hadjiantoni, BSc Hons, Principal investigator, Royal Cornwall Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635801
- Sponsor's protocol ID
- 2018.RCHT.53
- Acronym
- MAAP
- Status last verified
- Nov 2023
- First submitted
- 15 Aug 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention - The MAAP Trial
- ClinicalTrials.gov ID
- NCT03635801
- Acronym / sponsor ID
- MAAP / 2018.RCHT.53
- Conditions
- Coronary Artery Disease, Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to PI's unavailability
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 17 Aug 2018 (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.
Purpose of this clinical investigation: clinical evaluation/accuracy of HeartSciences MyoVista High-Sensitivity (hsECG) 12 lead Electrocardiogram device, for patients presenting with cardiac related chest pain and/or Non ST-segment Elevation Myocardial Infarction (NSTEMI). To assess the early intervention of N-STEMI patients. Determine if clinical outcomes can be improved. Assessment will be made on the MYOVISTA's indices, numerical values, and sensitivity/specificity for early detection of cardiac dysfunction/disease,i.e. Coronary Artery Disease (CAD). Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigation/procedure by way of angiography, thus improving the patient care pathway. Recruitment will take place at the Royal Cornwall Hospitals Trust, the Sponsor who will fund the research. A single centre study. Participants will undergo a 12 lead MyoVista ECG in addition to a standard 12 lead ECG. This is not an invasive procedure and carries no risk to the patient. There will be no change in the patient care pathway. The study will last c. 2 years, enrolment of patients ceasing once the statistically significant number to power the study has been met which is sufficient and ethical. Prerequisites for inclusion to the clinical investigation include:
- Signed informed consent prior to any procedure relating to the investigation
- Patient compliance with the clinical investigational plan
- Follow-up appointment(s) attendance
- Patient(s) presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
- Notable Electrocardiogram morphological changes, consistent with Myocardial Ischaemia (MI) i.e. T-wave inversion, Biphasic T-wave, ST-segment depression
- Symptom onset of <12 hrs
- Elevated High Sensitivity Troponin Score
- GRACE score of >140 It is hoped that > 75% of patients seen will show willingness and compliance throughout the duration of the clinical investigation. Clinical benefits, early diagnosis of heart disease, streamlined triage of patients, reduction in morbidity/mortality, reduction in costs to National Health Service (NHS) and improved patient centered care.
Detailed description
The purpose of this clinical investigation is the clinical evaluation and accuracy of HeartSciences MyoVista High-Sensitivity (hsECG) 12 lead Electrocardiogram devices, for patients presenting with cardiac chest pain and/or Non ST-segment Elevation Myocardial Infarction (NSTEMI). To assess the early intervention of N-STEMI patients and determine if clinical outcomes can be improved. In addition, assessment will be made on the MYOVISTA's indices, numerical values, and sensitivity/specificity for early detection of cardiac dysfunction/disease, namely Coronary Artery Disease (CAD). The Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigation/procedure by way of angiography, thus improving the patient care pathway. This clinical investigation will answer an important clinical question, i.e. can outcomes in 'high-risk' N-STEMI patients be improved with the intervention of MyoVista 12 lead Electrocardiogram in the detection of heart disease/diastolic dysfunction, compared to current standard practice?This clinical investigation anticipates that outcomes are improved in 'high-risk' patients when early detection and diagnosis is made using the MyoVista. The clinical investigation should therefore determine whether there is a need for a change in patient management, specifically those patients presenting as N-STEMI. This will allow for earliest intervention, with the results and data of this clinical investigation informing National/International guidelines, practice and healthcare service provision. The Primary endpoint will be the acute reperfusion/revascularization of target coronary vessels by way of Percutaneous Coronary Intervention (PCI) with specified follow-up at six (6) and twelve (12) months, with twelve (12) month being the specified termination of the clinical investigation plan.This clinical investigation is a prospective, single-centred Pilot study. The total investigation duration is expected to be approximately 2 - 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoVista 12 Lead (ECG) NSTEMI | – | Device: MyoVista 12 lead Electrocardiogram (ECG)Patients enrolling in this clinical investigation will undergo a standard 12-lead ECG using the MyoVista 12-lead hs ECG device. An ECG is a quick, safe and painless test. No electricity is put into the body while it's carried out. There may be some slight discomfort when the electrodes are removed from the skin - similar to removing a sticking plaster - and some people may develop a mild rash where the electrodes were attached. An ECG is performed under controlled conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non ST segment Myocardial Infarction (NSTEMI)
Key inclusion criteria (9 listed)
- Signed informed consent prior to any procedure relating to the investigation
- Patient compliance with the clinical investigational plan
- Follow-up appointment(s) attendance
- Patient(s) presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
- Notable Electrocardiogram morphological changes, consistent with Myocardial Ischaemia (MI) i.e. T-wave inversion, Biphasic T-wave, ST-segment depression
Key exclusion criteria (17 listed)
- Have a recent documented Myocardial Infarction within 40 days prior to enrolment and commencement of this investigation
- Have had a recent Trans-Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) within 3 months prior to enrolment and commencement of this investigation
- Have undergone cardiac surgery or coronary revascularisation within 3 months prior to enrolment and commencement of this investigation
- Be less than 18 years of age
- Involvement of vulnerable subjects (e.g. those lacking capacity to provide informed consent)
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 |
|---|---|---|
| MyoVista 12 lead Electrocardiogram (ECG)MyoVista 12 Lead Electrocardiogram (ECG) | Device | MyoVista 12 Lead (ECG) NSTEMI |
Primary outcome
The MAAP Trial
Time frame: Two Years
The primary outcome is one that the MyoVista is a good predictor of the need for an Angiogram in those patients presenting with cardiac related chest pain, more specifically, NSTEMI patients. The Primary objective is to ascertain the efficacy of the MyoVista and evaluate its usefulness in expediting those patients that require further investigation/procedure by way of angiography/angioplasty, thus improving the patient care pathway.
1 secondary outcome
The MAAP Trial
Time frame: Two Years
Results and safety
The study was stopped early (reason given: Due to PI's unavailability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Alexandros Hadjiantoni, BSc Hons principal investigator
Royal Cornwall Hospitals 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 Coronary Artery Disease and Diastolic Dysfunction, run by Royal Cornwall Hospitals Trust 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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 18 Nov 2023. 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 was stopped early (reason given: Due to PI's unavailability). Results are not available in the source record.
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?
The MAAP Trial (time frame: Two Years). 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 18 Nov 2023.