The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial

Trial details

Who runs it

Royal Cornwall Hospitals Trust

Trial code

NCT03635801

Record updated

18 November 2023

Original description

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:Read full original descriptionShow less

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.

Inclusion: 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: 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; 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; 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; 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; 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); 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.

ClinicalTrials.gov NCT03635801