The IPED (Investigation of Palpitations in the ED) Study

NCT02783898 | Completed Results

• 3 other identifiers: 2016/0153R15/A164PG/17/63/33198
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Presyncope; Arrhythmias, Cardiac; Tachycardia, Supraventricular; Atrial Fibrillation

Keywords

pre syncope, palpitations

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Symptomatic Rhythm Detection up to 90 Days

  Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.

  90 days

Secondary Outcomes (8)

• Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days

  90 days

• Time to Detection of Symptomatic Rhythm

  90 days

• Time to Detection of Cardiac Arrhythmia Rhythm

  90 days

• Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia

  90 days

• Number of Participants Finding the AliveCor Heart Monitor Easy to Use

  90 days

Study Arms (2)

Study

EXPERIMENTAL

All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.

Device: AliveCor Heart Monitor

Control

NO INTERVENTION

All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.

Interventions

AliveCor Heart Monitor DEVICE

Smart phone based ECG event recorder

Study

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (10)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

Chesterfield

Chesterfield, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Royal London Hospital, Barts NHS Trust

London, United Kingdom

Location

Whipps Cross Hospital, Barts NHS Trust

London, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Musgrove Park Hospital

Taunton, United Kingdom

Location

Related Publications (8)

• Thiruganasambandamoorthy V, Taljaard M, Stiell IG, Sivilotti ML, Murray H, Vaidyanathan A, Rowe BH, Calder LA, Lang E, McRae A, Sheldon R, Wells GA. Emergency department management of syncope: need for standardization and improved risk stratification. Intern Emerg Med. 2015 Aug;10(5):619-27. doi: 10.1007/s11739-015-1237-1. Epub 2015 Apr 28.

  PMID: 25918108 BACKGROUND

• Probst MA, Mower WR, Kanzaria HK, Hoffman JR, Buch EF, Sun BC. Analysis of emergency department visits for palpitations (from the National Hospital Ambulatory Medical Care Survey). Am J Cardiol. 2014 May 15;113(10):1685-90. doi: 10.1016/j.amjcard.2014.02.020. Epub 2014 Mar 1.

  PMID: 24698469 BACKGROUND

• Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE, Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013 Apr 30;165(1):193-4. doi: 10.1016/j.ijcard.2013.01.220. Epub 2013 Mar 7. No abstract available.

  PMID: 23465249 BACKGROUND

• Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, Bennett AA, Briffa T, Bauman A, Martinez C, Wallenhorst C, Lau JK, Brieger DB, Sy RW, Freedman SB. Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. The SEARCH-AF study. Thromb Haemost. 2014 Jun;111(6):1167-76. doi: 10.1160/TH14-03-0231. Epub 2014 Apr 1.

  PMID: 24687081 BACKGROUND

• Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, Chang PM, Saxon LA. Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations. J Cardiovasc Electrophysiol. 2015 May;26(5):520-6. doi: 10.1111/jce.12634. Epub 2015 Mar 19.

  PMID: 25651872 BACKGROUND

• Tarakji KG, Wazni OM, Callahan T, Kanj M, Hakim AH, Wolski K, Wilkoff BL, Saliba W, Lindsay BD. Using a novel wireless system for monitoring patients after the atrial fibrillation ablation procedure: the iTransmit study. Heart Rhythm. 2015 Mar;12(3):554-559. doi: 10.1016/j.hrthm.2014.11.015. Epub 2014 Nov 18.

  PMID: 25460854 BACKGROUND

• Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S, Keating L, Coffey F, Jones L, Harris T, Lloyd G, Gagg J, Smith JE, Coats T. 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. EClinicalMedicine. 2019 Mar 3;8:37-46. doi: 10.1016/j.eclinm.2019.02.005. eCollection 2019 Feb.

  PMID: 31193636 DERIVED

• Reed MJ, Grubb NR, Lang CC, O'Brien R, Simpson K, Padarenga M, Grant A, Tuck S. Multi-centre randomised controlled trial of a smart phone-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: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):711. doi: 10.1186/s13063-018-3098-1.

  PMID: 30594256 DERIVED

MeSH Terms

Conditions

Syncope; Arrhythmias, Cardiac; Tachycardia, Supraventricular; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Tachycardia; Cardiac Conduction System Disease

Results Point of Contact

• Title: Dr Matt Reed
• Organization: NHS Lothian

Matthew.Reed@nhslothian.scot.nhs.uk

+44 131 242 1448

Study Officials

• Matthew J Reed, MA FRCEM MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: May 26, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 1, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)