CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 243 enrolled
Drug / intervention
AliveCor Heart Monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02783898
NCT02783898N/ACompleted

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

NHS Lothian·interventional·Posted May 26, 2016·Updated Nov 19, 2019

In Brief

A clinical study evaluating AliveCor Heart Monitor for Presyncope and 3 related conditions. Completed, enrolled 243 participants across 10 sites.

Detailed Summary

Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose 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 discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult 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. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 26, 2016
Enrollment StartJun 1, 2016
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.1 years ago

Interventions

AliveCor Heart Monitordevice

Smart phone based ECG event recorder