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REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge -RCT (REMOSYNCED)

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ClinicalTrials.gov Identifier: NCT05066347
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Syncope (fainting) is a common reason for emergency department (ED) presentation. Fainting can be caused by heart conditions such as irregular heart rhythm (arrhythmia) that can be life-threatening, structural heart problems, or serious conditions not related to the heart. The standard or usual treatment for the majority of patients at-risk for irregular heart rhythm is getting discharged home with no heart rhythm monitoring. If patients receive any monitoring, only Holter monitoring device that records all heart beats for 24 hours to 72 hours will be used. One-third to half of irregular heart rhythm will be identified only after patients are either discharged from the ED or hospitalized in an inpatient unit. One-third to half of irregular heart rhythm will be identified only after patients are either discharged from the ED or hospitalized in an inpatient unit. The study hypothesize that prolonged live cardiac rhythm monitoring (15 days) of at-risk syncope patients, discharged from the ED, will lead to identification of irregular heart rhythm, which can lead to improved patient safety and lower healthcare costs.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge - A Multicenter Randomized Controlled Trial: REMOSYNCED
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 30, 2025
Estimated Study Completion Date : July 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
No Intervention: Usual care
Patients randomized to usual care will receive all care as prescribed by the discharging physician and there will be no study specific interventions. The current usual care varies from no outpatient monitoring to short-term Holter monitoring (24 hours to 72 hours).
Experimental: Prolonged 24/7 live outpatient cardiac rhythm monitoring
Patients randomized to the intervention arm will receive 24/7 live cardiac rhythm monitoring for 15 days. If a patient is randomized to the intervention arm and was prescribed outpatient cardiac monitoring such as Holter monitor, this will be replaced by the 24/7 live monitoring and will be applied either prior or within 24 hours of discharge from the ED.
Device: Cardiophone
Cardiophone (ER920W event recorder, Braemar Inc.) is an external loop recorder that has the monitoring and cell phone technology in one unit. Cardiophone evaluates all cardiac beats and rhythm abnormalities that are detected as per the algorithm programmed into the device. These abnormalities are then automatically and immediately transmitted to a central monitoring station in Windsor, Ontario (Canadian Cardiac Care) without the need of any patient intervention (device-triggered transmission). Additionally, the cardiac rhythm can also be transmitted to the monitoring station immediately in the event the patient experiences symptoms, by the touch of a button on the device (patient-triggered transmission).




Primary Outcome Measures :
  1. Number of participants with arrhythmia that required treatment [ Time Frame: within 15-days of the index ED visit ]
    Identification of an arrhythmia that required treatment among at-risk syncope patients discharged from the ED among patients with CSRS score ≥3.


Secondary Outcome Measures :
  1. Number of participants with arrhythmias that did not require treatment [ Time Frame: within 15-days of the index ED visit; between 16 and 30 days of disposition ]
    Arrhythmias that did not require treatment

  2. Rate of Mortality [ Time Frame: 1-year ]
    Distinguishing between deaths secondary to another serious condition and due to an unknown cause

  3. Number of participants with non-arrhythmic serious conditions [ Time Frame: within 30-days of disposition ]
    non-arrhythmic serious conditions

  4. Number of return ED visits [ Time Frame: 1-year ]
    Proportion of patients had return ED visits

  5. Rate of Hospitalizations [ Time Frame: 1-year ]
    Proportion of patients hospitalized

  6. Device Insertion [ Time Frame: 1-year ]
    Proportion of patients with device insertions [pacemaker, implantable cardiac defibrillator (ICD), or a combined pacemaker-ICD device]

  7. Any serious outcome [ Time Frame: within 30 days ]
    The occurrence and identification of any serious outcome for lower-risk patients (CSRS score <3).



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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:

  • Adult patients (aged ≥ 18 years old) who present with syncope to any of the study EDs (within 24 hours), are classified as medium (3-5,) or high-risk (≥6) as per the CSRS and are being discharged from the ED either by the ED team or the consulting team if consulted to another service. Patients will be enrolled after written consent.
  • For the secondary objectives related to the embedded observational study, validation of the CSRS ultra-low-risk criteria and to evaluate if the CSRS can be updated to improve its accuracy, ED physicians will obtain verbal consent from patients who are lower risk (score <3). These patients will not be enrolled in the randomized controlled trial.

Exclusion Criteria:

  • Prolonged loss of consciousness (i.e., > 5 minutes),
  • Glasgow Coma Scale < 15 in patients without dementia (or a change in the mental status from baseline in those with dementia);
  • Witnessed obvious seizure, or head trauma preceding the loss of consciousness; and those who are unable to provide proper details (e.g., alcohol intoxication or other substance use).
  • Patients who are hospitalized on their index ED visit and who had an obvious underlying serious condition for the syncope identified during the index ED visit

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): NCT05066347


Contacts
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Contact: Bahareh Ghaedi, MSc, CCRA 613-823-1299 bghaedi@ohri.ca
Contact: Phuong Anh (Iris) Nguyen, BSc 613-823-1299 pnguyen@ohri.ca

Locations
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Canada, Ontario
The Ottawa Hospital - Civic and General Campuses Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Bahareh Ghaedi, MSc    613-823-1299    Bhghaedi@ohri.ca   
Contact: Phuong Anh (Iris) Nguyen, BSc    613-823-1299    pnguyen@ohri.ca   
Principal Investigator: Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Venkatesh Thiruganasambandamoorthy Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT05066347    
Other Study ID Numbers: 3781
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Syncope
Cardiac monitoring
Emergency Department
Additional relevant MeSH terms:
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Syncope
Emergencies
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases