Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03635801
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2018-08-15
Brief Title:
The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial
Sponsor:
Royal Cornwall Hospitals Trust
Organization:
Royal Cornwall Hospitals Trust
Study Overview
Official Title:
The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention - The MAAP Trial
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to PIs unavailability
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAAP
Brief Summary:
Purpose of this clinical investigation clinical evaluationaccuracy of HeartSciences MyoVista High-Sensitivity hsECG 12 lead Electrocardiogram device for patients presenting with cardiac related chest pain andor 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 MYOVISTAs indices numerical values and sensitivityspecificity for early detection of cardiac dysfunctiondiseaseie Coronary Artery Disease CAD Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigationprocedure 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 appointments attendance
Patients presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
Notable Electrocardiogram morphological changes consistent with Myocardial Ischaemia MI ie 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 morbiditymortality reduction in costs to National Health Service NHS and improved patient centered care
Signed informed consent prior to any procedure relating to the investigation
Patient compliance with the clinical investigational plan
Follow-up appointments attendance
Patients presenting to hospital with a clinical diagnosis of Non ST-segment Elevation Myocardial Infarction
Notable Electrocardiogram morphological changes consistent with Myocardial Ischaemia MI ie 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 morbiditymortality 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 andor 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 MYOVISTAs indices numerical values and sensitivityspecificity for early detection of cardiac dysfunctiondisease namely Coronary Artery Disease CAD The Primary objective to ascertain efficacy of the MyoVista and evaluate its usefulness in expediting patients that require further investigationprocedure by way of angiography thus improving the patient care pathway This clinical investigation will answer an important clinical question ie can outcomes in high-risk N-STEMI patients be improved with the intervention of MyoVista 12 lead Electrocardiogram in the detection of heart diseasediastolic dysfunction compared to current standard practiceThis 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 NationalInternational guidelines practice and healthcare service provision The Primary endpoint will be the acute reperfusionrevascularization 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 planThis clinical investigation is a prospective single-centred Pilot study The total investigation duration is expected to be approximately 2 - 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None