N/A
N=242
The IPED (Investigation of Palpitations in the ED) Study
Presyncope · Arrhythmias, Cardiac · Tachycardia, Supraventricular · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02783898 ↗Enrolled (actual)
242
Serious AEs
5.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Symptomatic Rhythm Detection up to 90 Days — 69; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AliveCor Heart Monitor (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- NHS Lothian
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Symptomatic Rhythm Detection up to 90 Days |
69; 11 | — |
| SECONDARY Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days |
11; 1 | — |
| SECONDARY Time to Detection of Symptomatic Rhythm |
9.5; 42.9 | — |
| SECONDARY Time to Detection of Cardiac Arrhythmia Rhythm |
9.9; 48 | — |
| SECONDARY Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia |
12; 6 | — |
| SECONDARY Number of Participants Finding the AliveCor Heart Monitor Easy to Use |
48; 32; 33; 4; 8 | — |
| SECONDARY Financial Cost Per Diagnosis of Symptomatic Rhythm |
474; 1395 | — |
| SECONDARY Number of Participants With Serious Outcome up to 90 Days |
11; 2 | — |
| SECONDARY Number of Participants Completing Questionnaire |
92; 33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participant aged 16 years or over
- Participant presenting with an episode of palpitations or pre-syncope
- Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.
Exclusion Criteria
- Prior diagnostic ECG
- Palpitations or pre-syncope present during an admission ECG
- Frequent episodes (i.e. at least once a day)
- Participants under 16 years of age
- Previous participation in the study
- Inability or unwilling to give informed consent.
- Participants with recent (i.e. within 3 months) myocardial infarction, severe heart failure (NYHA class 4) or unstable angina
- Participants unwilling or unable to use the AliveCor Heart Monitor and AliveECG app
- Participants without a compatible smart phone or tablet
- Participants with cardiac pacemakers or other implanted electronic devices
- No telephone number for follow-up
- Participant in custody
Data sourced from ClinicalTrials.gov (NCT02783898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.