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NCT03635801: MAAP

The MyoVista Angiography Angioplasty Percutaneous Coronary Intervention Trial

Terminated Last updated 18 November 2023
What this trial tests

trial testing MyoVista 12 lead Electrocardiogram (ECG) in Coronary Artery Disease in 126 participants. Terminated before completion.

Timeline
1 January 2019
Primary endpoint
16 November 2023
16 November 2023

Quick facts

Lead sponsorRoyal Cornwall Hospitals Trust
StatusTerminated
Study typeOBSERVATIONAL
Enrollment126
Start date1 January 2019
Primary completion16 November 2023
Estimated completion16 November 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Royal Cornwall Hospitals Trust

Who can join

18 and older, any sex, with Coronary Artery Disease or Diastolic Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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: * 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Royal Cornwall Hospitals Trust trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03635801.

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