HMS

• Research type

  Research Study

• Full title

  Hearts and Minds Study

• IRAS ID

  306966

• Contact name

  Nicholas Peters

• Contact email

  n.peters@imperial.ac.uk

• Sponsor organisation

  Imperial College Healthcare NHS Trust

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Aims:

  To validate the performance of an artificial intelligence-enabled stethoscope for detection of three cardiovascular diseases (heart failure with reduced ejection fraction; heart valve disease and irregular heart rhythm), all compared with the gold-standard investigations for these diseases (echocardiography and MRI)

  To measure the patient-reported and clinical benefits of a Care Navigation service for patients at high risk of cardiovascular disease.

  Design:

  Head-to-head comparison of the performance of artificial intelligence (AI) algorithms in detecting (a) left ventricular ejection fraction (LVEF) above or below 40%, (b) heart valve disease and (c) an irregular heart rhythm (atrial fibrillation), against the gold standard investigations – echocardiography and cardiac MRI.
  
  A randomised study to determine the effectiveness of a Care Navigation service for patients at high risk of cardiovascular disease.

  Methods
  All participants will use a smart stethoscope (‘Eko DUO’) to briefly record their heart sounds and heart rhythm (electrocardiogram, ECG). The research team will repeat these recordings. The AI within the Eko DUO predicts the presence or absence of cardiovascular disease, which the research team will compare to the gold-standard investigations that the patient is having as part of their routine care.

  A sub-study of participants who are at high risk of cardiovascular disease will randomly allocate participants to receive:
  A ‘smartwatch’, called a Fitbit, plus a structured ‘Care Navigation’ programme
  A Fitbit plus an unstructured ‘Care Navigation’ programme
  Usual care.

  The sub-study will measure patient quality of life and confidence in managing their healthcare.

  Outcomes: The primary outcome is the accuracy of the AI for detecting cardiovascular disease.

  Secondary outcomes include:
  Reproducibility of recordings made by patients and clinicians
  Patient usability of the Eko DUO stethoscope and a hand-held ECG device called a KardiaMobile
  Patient Activation Measure (PAM), which is a measurement of a patient’s engagement and confidence in managing their own health.
  Physical activity
  

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  22/LO/0337

• Date of REC Opinion

  24 Aug 2022

• REC opinion

  Further Information Favourable Opinion