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Trial record 31 of 42 for:    Syncope | Child

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 1, 2019
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

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.

Condition or disease Intervention/treatment Phase
Presyncope Arrhythmias, Cardiac Tachycardia, Supraventricular Atrial Fibrillation Device: AliveCor Heart Monitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : June 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
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.
Device: AliveCor Heart Monitor
Smart phone based ECG event recorder

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783898


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Chesterfield
Chesterfield, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Royal London Hospital, Barts NHS Trust
London, United Kingdom
Whipps Cross Hospital, Barts NHS Trust
London, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital
Plymouth, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Sponsors and Collaborators
NHS Lothian
Investigators
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Principal Investigator: Matthew J Reed, MA FRCEM MD NHS Lothian
  Study Documents (Full-Text)

Documents provided by NHS Lothian:
Statistical Analysis Plan  [PDF] June 12, 2018
Study Protocol  [PDF] October 9, 2016


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT02783898     History of Changes
Other Study ID Numbers: 2016/0153
R15/A164 ( Other Identifier: Chest Heart Stroke Scotland )
PG/17/63/33198 ( Other Grant/Funding Number: British Heart Foundation )
First Posted: May 26, 2016    Key Record Dates
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NHS Lothian:
pre syncope, palpitations
Additional relevant MeSH terms:
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Syncope
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Tachycardia, Supraventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms