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

NCT05066347 | Recruiting DMC

• 1 other identifier: 3781
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope

Keywords

Syncope; Cardiac monitoring; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Number of participants with arrhythmia that required treatment

  Identification of an arrhythmia that required treatment among at-risk syncope patients discharged from the ED among patients with CSRS score ≥3.

  within 15-days of the index ED visit

Secondary Outcomes (7)

• Number of participants with arrhythmias that did not require treatment

  within 15-days of the index ED visit; between 16 and 30 days of disposition

• Rate of Mortality

  1-year

• Number of participants with non-arrhythmic serious conditions

  within 30-days of disposition

• Number of return ED visits

  1-year

• Rate of Hospitalizations

  1-year

Study Arms (2)

Usual care

NO INTERVENTION

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).

Prolonged 24/7 live outpatient cardiac rhythm monitoring

EXPERIMENTAL

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 Plus

Interventions

Cardiophone Plus DEVICE

Cardiophone Plus (Bittium Faros 360 Mobile event recorder, Bittium Biosignals Ltd., Finland., an external loop recorder with 3 leads for 2 channels. Cardiophone Plus 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 without the need for any patient intervention (device-triggered transmission). This transmission occurs through the cell phone that comes with the device. The central monitoring station is in Windsor, Ontario (Canadian Cardiac Care) and is staffed round the clock by certified electrocardiographic technicians and a cardiologist on-call.

Prolonged 24/7 live outpatient cardiac rhythm monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital - Civic and General Campuses

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Venkatesh Thiruganasambandamoorthy

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Nguyen, BSc

CONTACT

613-798-5555; pnguyen@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 4, 2021
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)