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Remote Cardiac Monitoring of Higher-Risk Emergency Department Syncope Patients After Discharge (REMOSYNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786940
Recruitment Status : Unknown
Verified April 2017 by Ottawa Hospital Research Institute.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

2-3% of emergency department (ED) syncope patients suffer arrhythmia/death within 30-days of disposition (either as inpatient or at home) and the investigators recently developed the Canadian Syncope Arrhythmia Risk Score (CSARS) to predict these outcomes. Currently, only holter monitoring is used and is applied a few days later. New and innovative remote (out-of-hospital) external cardiac monitoring technology has made prolonged monitoring possible with live automatic and patient triggered cardiac rhythm transmission to a central monitoring station.

Objective: To conduct a multicenter two-arm open label RCT among higher-risk (CSARS score≥3) ED syncope patients discharged home for comparing the diagnostic yield (detection of serious arrhythmias that required treatment or exclusion of arrhythmia) at the end of 15-days between a 15-day event monitor (intervention) and usual care (48-hour holter with patients seeking care after 48-hours based on symptoms) at 10 Canadian EDs.

Methods: Cardiophone (live monitor) will be used for the intervention arm and the Mobile Cardiac Telemetry (MCT) device will be used for the control arm and both devices applied prior to ED discharge. MCT will function as a holter for first 48-hours and then as an event recorder (days 3-15) for arrhythmia surveillance. After written informed consent, patients will be randomized 1:1 with allocation concealed by web-based randomization and stratified based on the total CSARS scores. All patients will be linked to a study cardiologist and will have follow-up after 15-days. If serious arrhythmias are detected by Cardiophone, the patient will be transported to ED and for non-serious arrhythmias, an interim report sent to the study cardiologist for follow-up. All monitoring reports will be sent to the cardiologist within 24-hours of completion. Data collection: patient demographics, medical history, score predictors, device data (failure, false alarms, duration worn), patient symptoms and comfort. Primary outcome will be diagnostic yield at 15-days in the two study arms and primary analysis will compare the diagnostic yield by intention to treat principle controlling for the stratification factor. Sample Size: 300 patients per arm (600 total) to detect a 10% difference in diagnostic yield between the arms.

Impact: Our study will increase early identification of patients with serious underlying arrhythmia by combining the CSARS risk tool with innovative remote monitoring technology.


Condition or disease Intervention/treatment Phase
Syncope Arrhythmia Device: Cardiophone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Remote Cardiac Monitoring of Higher-Risk Emergency Department Syncope Patients After Discharge
Actual Study Start Date : October 24, 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia Fainting

Arm Intervention/treatment
Experimental: Live Remote Cardiac Monitoring
Live remote cardiac monitoring with transmission of cardiac rhythm (device-triggered: if rhythm abnormalities detected by device algorithm; or patient-triggered by pressing the transmit button because of symptoms) for 15 days.
Device: Cardiophone
Remote live monitoring for 15 days for detection or exclusion of arrhythmias
Other Name: ER920W event recorder, Braemar Inc

Active Comparator: Usual Care
Mobile Cardiac Telemetry (PocketECG; Medicalgorithmics S.A) will be used in the control arm. This device combines holter, event monitoring and mobile cardiac telemetry (continuous live cardiac monitoring of every single beat) into one unit. The holter functionality will be used for the first 48 hours (usual care). The diagnostic yield from the 48 hour holter monitoring and patients seeking care based on their symptoms for the additional 13 days will be compared to the 15-day live monitoring.
Device: Cardiophone
Remote live monitoring for 15 days for detection or exclusion of arrhythmias
Other Name: ER920W event recorder, Braemar Inc




Primary Outcome Measures :
  1. Proportion of participants among whom arrhythmias are detected or excluded [ Time Frame: 15-days ]
    The primary outcome will be the diagnostic yield and includes detection of serious arrhythmias that required treatment or that caused death, or exclusion of arrhythmia by symptom-rhythm correlation within 15-days of the index ED visit. The investigators will collect data on the type of treatment offered (medications; implantable loop recorder, pacemaker, defibrillator, or dual device insertions; cardioversion or therapeutic ablation). A blinded Adjudication Committee of 3 physicians will confirm all outcomes.


Secondary Outcome Measures :
  1. Safety of the live monitoring device [ Time Frame: 15 days ]

    The investigators will report the proportion of patients with adverse events due to device failure.

    In both arms:

    1. The duration of time the devices were worn will be reported.
    2. The proportion of patients with arrhythmias that did not require treatment will be reported.

  2. Compliance of the participants in wearing the devices [ Time Frame: 15 days ]
    The duration the devices were worn will be reported

  3. Detection of arrhythmias that did not require treatment [ Time Frame: 15 days ]
    The proportion of patients among whom arrhythmias that did not require treatment will be reported in the two arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (age ≥18 years) patients with syncope
  2. High-risk as per the Canadian Syncope Arrhythmia Risk Score (score > or =3)and being discharged home after ED physician or consultant assessment.

Exclusion Criteria:

  1. Syncope patients with a score <3
  2. Those who are hospitalized
  3. Previously enrolled.
  4. Loss of consciousness not related to syncope: prolonged loss of consciousness > 5 minutes
  5. Change in the mental status from baseline
  6. Patients with alcohol intoxication or illicit drug abuse, witnessed obvious seizure; or head trauma, i.e. trauma the initial event.

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): NCT02786940


Contacts
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Contact: Soo-Min Kim, BScH 613-798-5555 ext 19347 sokim@ohri.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Vi Ho, MD    604-875-4205    vi.ho@vch.ca   
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Soo-Min Kim, BScH    613-798-5555 ext 19347    sokim@ohri.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Venkatesh Thiruganasambandamoorthy, MBBS Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02786940    
Other Study ID Numbers: 20160119-01H
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ottawa Hospital Research Institute:
remote
cardiac monitoring
mortality
Additional relevant MeSH terms:
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Syncope
Emergencies
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases