The IPED study
Research type
Research Study
Full title
Randomised controlled trial of the use of a smart phone based event recorder versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope
IRAS ID
196616
Contact name
Matthew Reed
Contact email
Sponsor organisation
ACCORD (Academic and Clinical Central Office for Research & Development)
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal heart rhythm. Diagnosis is difficult as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually advised to return to the ED for a 12-lead ECG should symptoms recur. We will recruit 242 participants aged 16 years or over presenting to the ED or Medical Assessment Unit of the Royal Infirmary of Edinburgh with an episode of palpitations or pre-syncope and who remain undiagnosed after ED assessment. We will randomise and allocate participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. If a participant allocated to the study arm has palpitations or pre-syncope during the 90-day study period, they can record an ECG using the AliveCor Monitor which can be viewed by the study team. Participants will be asked to log symptoms and whether they were able to record an ECG during the symptoms in a participant symptom diary, which they will return to the research team along with the Participant satisfaction and compliance questionnaire, and smart phone based event recorder at the end of the 90 days in a pre-paid stamped, addressed envelope. Participants will be phoned at 90 days to remind them to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. We believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
REC name
South East Scotland REC 02
REC reference
16/SS/0074
Date of REC Opinion
29 Apr 2016
REC opinion
Favourable Opinion