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The IPED (Investigation of Palpitations in the ED) Study (IPED)

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ClinicalTrials.gov Identifier: NCT02783898
Recruitment Status : Completed
First Posted : May 26, 2016
Results First Posted : November 1, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE May 26, 2016
Results First Submitted Date  ICMJE September 16, 2019
Results First Posted Date  ICMJE November 1, 2019
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
Number of Participants With Symptomatic Rhythm Detection up to 90 Days [ Time Frame: 90 days ]
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care. [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days [ Time Frame: 90 days ]
    Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
  • Time to Detection of Symptomatic Rhythm [ Time Frame: 90 days ]
    Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
  • Time to Detection of Cardiac Arrhythmia Rhythm [ Time Frame: 90 days ]
    Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
  • Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia [ Time Frame: 90 days ]
    Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care
  • Number of Participants Finding the AliveCor Heart Monitor Easy to Use [ Time Frame: 90 days ]
    Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
  • Financial Cost Per Diagnosis of Symptomatic Rhythm [ Time Frame: 90 days ]
    Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
  • Number of Participants With Serious Outcome up to 90 Days [ Time Frame: 90 days ]
    Number of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).
  • Number of Participants Completing Questionnaire [ Time Frame: 90 days ]
    Measure of questionnaire compliance - Number of participants completing questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care [ Time Frame: 90 days ]
  • Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care [ Time Frame: 90 days ]
  • Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care [ Time Frame: 90 days ]
  • Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care [ Time Frame: 90 days ]
  • Participant monitor satisfaction via questionnaire [ Time Frame: 90 days ]
    Participant questionnaire: (1) The AliveCor heart monitor was easy to use (2) The AliveCor heart monitor will be useful in diagnosing the cause of my symptoms
  • Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care. [ Time Frame: 90 days ]
  • Composite 90 day serious outcome: number of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire). [ Time Frame: 90 days ]
  • Participant monitor compliance via questionnaire [ Time Frame: 90 days ]
    Participant questionnaire: (1) The AliveCor heart monitor was always available when I had symptoms and needed to record my heart tracing? (2) I had no problems recording a heart tracing using the AliveCor app (3) I had no problems sending a heart tracing to the study team using the AliveCor app (4) During the study period I was able to record a heart tracing when I had similar symptoms to the time I initially visited the Emergency Department
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The IPED (Investigation of Palpitations in the ED) Study
Official Title  ICMJE 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
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.
Detailed Description 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. The investigators 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. The investigators 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, the participant 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 the participant was able to record an ECG during the symptoms in a participant symptom diary, which the participant 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 the participant to complete the Participant satisfaction and compliance questionnaire and to return this with the symptom diary and smart phone based event recorder. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Presyncope
  • Arrhythmias, Cardiac
  • Tachycardia, Supraventricular
  • Atrial Fibrillation
Intervention  ICMJE Device: AliveCor Heart Monitor
Smart phone based ECG event recorder
Study Arms  ICMJE
  • Experimental: Study
    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.
    Intervention: Device: AliveCor Heart Monitor
  • No Intervention: Control
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
243
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
242
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant aged 16 years or over
  2. Participant presenting with an episode of palpitations or pre-syncope
  3. Participant's underlying ECG rhythm during these episodes remains undiagnosed after clinical assessment.

Exclusion Criteria:

  1. Prior diagnostic ECG
  2. Palpitations or pre-syncope present during an admission ECG
  3. Frequent episodes (i.e. at least once a day)
  4. Participants under 16 years of age
  5. Previous participation in the study
  6. Inability or unwilling to give informed consent.
  7. Participants with recent (i.e. within 3 months) myocardial infarction, severe heart failure (NYHA class 4) or unstable angina
  8. Participants unwilling or unable to use the AliveCor Heart Monitor and AliveECG app
  9. Participants without a compatible smart phone or tablet
  10. Participants with cardiac pacemakers or other implanted electronic devices
  11. No telephone number for follow-up
  12. Participant in custody
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02783898
Other Study ID Numbers  ICMJE 2016/0153
R15/A164 ( Other Identifier: Chest Heart Stroke Scotland )
PG/17/63/33198 ( Other Grant/Funding Number: British Heart Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NHS Lothian
Study Sponsor  ICMJE NHS Lothian
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew J Reed, MA FRCEM MD NHS Lothian
PRS Account NHS Lothian
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP