Clinical trial NCT03635801: The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial
Official title: The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention - The MAAP Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Diastolic Dysfunction
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non ST segment Myocardial Infarction (NSTEMI)

Brief 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). 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.

Eligibility criteria: Inclusion Criteria: Inclusion Criteria

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
* Symptom onset of \<12 hrs
* Elevated High Sensitivity Troponin Score
* GRACE score of \>140

Exclusion Criteria: Exclusion Criteria

* 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
* 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.

Primary outcomes:
measure: The MAAP Trial
timeFrame: Two Years
Secondary outcomes:
measure: The MAAP Trial
timeFrame: Two Years
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
affiliation: Royal Cornwall Hospitals Trust
name: Alexandros Hadjiantoni, BSc Hons
role: PRINCIPAL_INVESTIGATOR
References: