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Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study.

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posted on 07.10.2019, 08:21 by MJ Reed, NR Grubb, CC Lang, R O'Brien, K Simpson, M Padarenga, A Grant, S Tuck, L Keating, F Coffey, L Jones, T Harris, G Lloyd, J Gagg, JE Smith, T Coats
Background: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation. Methods: Multi-centre open label, randomised controlled trial. Participants ≥ 16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smartphone-based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Trial registration number NCT02783898 (ClinicalTrials.gov). Findings: Two hundred forty-three participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n = 124; 55.6%; 95% CI 46.9-64.4%) participants in the intervention group versus 11 (n = 116; 9.5%; 95% CI 4.2-14.8) in the control group (RR 5.9, 95% CI 3.3-10.5; p < 0.0001). Mean time to symptomatic rhythm detection in the intervention group was 9.5 days (SD 16.1, range 0-83) versus 42.9 days (SD 16.0, range 12-66; p < 0.0001) in the control group. The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats. A symptomatic cardiac arrhythmia was detected at 90 days in 11 (n = 124; 8.9%; 95% CI 3.9-13.9%) participants in the intervention group versus 1 (n = 116; 0.9%; 95% CI 0.0-2.5%) in the control group (RR 10.3, 95% CI 1.3-78.5; p = 0.006). Interpretation: Use of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold to more than 55% at 90 days. This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope. Funding: This study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and British Heart Foundation (BHF) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award.

Funding

The study was funded by Chest, Heart and Stroke Scotland (Action Research Grant R15/A164; £23,056) and British Heart Foundation (BHF Project Grant no. PG/17/63/33198; £21,347) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit.

History

Citation

EClinicalMedicine, 2019, 8, pp. 37-46

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Cardiovascular Sciences

Version

VoR (Version of Record)

Published in

EClinicalMedicine

Publisher

Elsevier

eissn

2589-5370

Acceptance date

15/02/2019

Copyright date

2019

Available date

07/10/2019

Publisher version

https://www.sciencedirect.com/science/article/pii/S2589537019300264?via=ihub

Notes

The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

Language

en