Real Care Version 1.4
Research type
Research Study
Full title
Reveal and Carelink (Real Care): Does Using Remote Monitoring in Combination with Implantable Loop Recorders Reduce the Time to Diagnosis? A Randomised Controlled Trial
IRAS ID
115687
Contact name
Gareth Pounds
Contact email
Sponsor organisation
County Durham and Darlington NHS Foundation Trust
Research summary
Implantable loop recorders (ILRs) are small diagnostic devices for monitoring and recording cardiac electrical signals/electrocardiographs (ECGs) for extended periods of time, the device can be implanted for up to 36 months in some cases. ILRs are implanted under local anaesthetic just beneath the skin, most often on the left side of the chest.
The main indication for ILRs is loss of conciousness or blackouts that are either believed to be cardiac in origin or remain unexplained and could pose a danger to the patient or others.
Currently County Durham and Darlington Foundation Trust (CDDFT) hospitals follow up ILRs at 1 month post implant and then at 6 monthly intervals as per departmental policy. Anecdotally it is suggested that other centres in the region have less frequent protocols for ILR follow-up with some centres only following up annually and others only following up if symptoms occur.
While ILRs are considered an effective tool, the recorders suffer from memory saturation, meaning that events are logged in lists but no ECGs are available. The current method of in-office follow up can promote memory saturation and potentially prolong diagnosis and or treatment.
A recent advance in ILRs has made the use of remote/home monitoring available as an alternative, or as a supplement to in-office follow up. There is readily available research for the effective use of remote monitoring with other implantable cardiac devices but little to none for ILRs.
The research proposal is for a randomised controlled trial to compare the two methods of follow-up. The research will identify how well patients accept the remote monitoring system and if it can improve our time to diagnosis pathway.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0297
Date of REC Opinion
4 Nov 2013
REC opinion
Favourable Opinion