THE MAAP TRIAL V001
Research type
Research Study
Full title
MyoVista Angiography Angioplasty Percutaneous Coronary Intervention –The MAAP Trial
IRAS ID
253138
Contact name
ALEXANDROS HADJIANTONI
Contact email
Sponsor organisation
Royal Cornwall Hospitals Trust RCHT
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of this study is to clinically evaluate the 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. Recriutment will take place at the Royal Cornwall Hospital, who are the Sponsors of this single centre study. Participants will undergo a 12 lead MyoVista ECG in addittion 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 \napproximately 2 years. Enrolment of patients will cease once the recruitment target has been satisfactorily met. Prerequisites for inclusion to the clinical investigation include:\n•\tSigned informed consent prior to any procedure relating to the investigation\n•\tPatient compliance with the clinical investigational plan\n•\tFollow-up appointment(s) attendance\n•\tPatient(s) presenting to hospital with a clinical diagnosis of Non ST- segment Elevation Myocardial Infarction\n•\tNotable Electrocardiogram morphological changes, consistent with Myocardial Ischaemia (MI) i.e. T-wave inversion, Biphasic T-wave, ST-segment depression\n•\tSymptom onset of <12 hrs\n•\tElevated High Sensitivity Troponin Score\n•\tGRACE score of >140\nIt is hoped that >75% of patients seen, will participate and remain compliant throughout the duration of the clinical investigation. Clinical benefits include 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.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0259
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion