Easy ECG V1
Research type
Research Study
Full title
A multicEntre trial to AssesS the validitY of the Kardia six lead hand-held ECG in psychiatry
IRAS ID
356658
Contact name
George Crowther
Contact email
ISRCTN Number
ISRCTN94157188
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Twelve lead electrocardiograms (ECGs) are regularly performed in psychiatry, as antipsychotic medication can affect cardiac repolarisation. This is represented on the ECG as QT prolongation. There are patient and system barriers to obtaining ECGs in psychiatry, such they are not done as frequently as they should be and obtaining one can cause treatment delays.
The Kardia 6L (K6L) is a small, handheld device that records a six lead ECG. It is less intrusive than a conventional 12L ECG (12L) as there is no need for undressing or skin electrodes. As it is easier and quicker to record a K6L ECG compared to a 12L, the K6L is likely to improve compliance, patient safety and improve efficiency.
A NICE evaluation concluded that there was little evidence for the safety or system and economic benefits of the K6L in psychiatry. They suggested further studies were needed to generate an evidence base in this group of patients before full adoption. To address the gap, this multicentre study will evaluate the safety, and potential patient benefits of the K6L in people with mental illness requiring antipsychotics.
We will test the diagnostic accuracy of the K6L compared to the 12L for the QT interval in people with mental illness requiring antipsychotics. Over a year long period we will recruit 800 participants from 10 different adoption sites in England and Wales serving a diverse population. Participants will undergo both a K6L and 12L for this comparison. We will also survey patients and healthcare professionals to assess the acceptability of the K6L and describe any observed clinical impact and efficiency savings. Finally, we will use the data to describe the prevalence of QT prolongation in people requiring antipsychotics.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
25/YH/0173
Date of REC Opinion
27 Oct 2025
REC opinion
Further Information Favourable Opinion