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Completed

NCT Number: NCT02783898

The IPED (Investigation of Palpitations in the ED) Study

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh, Edinburgh, Midlothian, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AliveCor Heart Monitor

Device

Smart phone based ECG event recorder

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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).

  8. Number of Participants Completing Questionnaire

    Time frame: 90 days

    Measure of questionnaire compliance - Number of participants completing questionnaire

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Registry information

Official study title

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

Acronym: IPED

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 26, 2016
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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