The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial

NCT03635801 | Terminated DMC

• 1 other identifier: 2018.RCHT.53
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  Two Years

Secondary Outcomes (1)

• The MAAP Trial

  Two Years

Study Arms (1)

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.

Device: MyoVista 12 lead Electrocardiogram (ECG)

Interventions

MyoVista 12 lead Electrocardiogram (ECG) DEVICE

MyoVista 12 Lead Electrocardiogram (ECG)

MyoVista 12 Lead (ECG) NSTEMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non ST segment Myocardial Infarction (NSTEMI)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Cornwall Hospitals Trust: lead

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alexandros Hadjiantoni, BSc Hons

  Royal Cornwall Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: January 1, 2019
• Primary Completion: November 16, 2023
• Study Completion: November 16, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)