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The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial

NCT03635801 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

DEVICE

MyoVista 12 lead Electrocardiogram (ECG)

MyoVista 12 Lead Electrocardiogram (ECG)

Sponsors & Collaborators

  • Royal Cornwall Hospitals Trust

    lead OTHER

Principal Investigators

  • Alexandros Hadjiantoni, BSc Hons · Royal Cornwall Hospitals Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-11-16
Completion
2023-11-16

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635801 on ClinicalTrials.gov