AliveCor
Research type
Research Study
Full title
Assessment of remote heart rhythm sampling to screen an at risk population of Atrial Fibrillation
IRAS ID
163540
Contact name
Tara Ghuman
Contact email
Sponsor organisation
ABMU Local Health Board
Duration of Study in the UK
2 years, 6 months, 29 days
Research summary
Atrial fibrillation (AF) is the most common type of arrhythmia 1,2,3,4, the presence of AF increases the incidence of stroke six fold5. Anticoagulation using well validated and simple risk stratification tools 6, 7 has been shown to reduce the risk of stroke by 70%.
The episodes of atrial fibrillation can be asymptomatic; the risk of stroke is no less for the asymptomatic nature of the episodes. Any assessment of heart rhythm is a snap shot in time and in part relies on serendipity to identify patients with asymptomatic paroxysmal atrial fibrillation.
Primary care work has looked at the utility of random opportunistic pulse checks to identify possible patients with AF 9, 10, and this has shown to be a cost effective way of identifying patients with AF. This paradigm requires attendance to primary care, a subsequent Electro Cardio Graph (ECG) to be performed and a confident interpretation of the ECG trace. It remains a ‘one off’ check.
The AliveCor monitoring system allows simple administered heart rhythm sampling and interpretation. The interpretation of the rhythm strip by the web based AliveCor system has been validated11, and provides a rapid interpretation of heart rhythm that does not impact upon a busy primary care practice.
It is proposed that the AliveCor system will be trialed as a means of identifying patients with atrial fibrillation in the community to facilitate earlier diagnosis and treatment and reduce the incidence of major cardiovascular events (notably stroke).
The trial is a randomised controlled clinical study designed to assess the monitoring systems utility in an asymptomatic high risk population based in the community.
Improving health and well being improves quality of life and can reduce the need for health and care services. The study will assess the feasibility of a simple patient driven monitoring strategy that could impact upon the incidence of stroke by allowing earlier detection of AF and outpatient treatment to prevent stroke.
AF is associated with a fivefold increase in stroke, and anticoagulation is well established as a successful intervention in at risk patients to reduce the risk of stroke. The risk reduction has been shown to be in the order of 70%.
REC name
Wales REC 6
REC reference
14/WA/1189
Date of REC Opinion
16 Oct 2014
REC opinion
Unfavourable Opinion