Recruiting

Prolonged Monitoring

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05066347

Conditions

Syncope

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiophone Plus

Study Details

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

Study ID

NCT05066347

Start date

Jul 1, 2022

Status verified date

Dec, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

580 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiophone Plus

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.

Primary outcome measure

  • Number of participants with arrhythmia that required treatment [ Time Frame: within 15-days of the index ED visit ]

Central Contacts and Locations

Central contacts

Iris Nguyen, BSc

613-798-5555pnguyen@ohri.ca

Locations

The Ottawa Hospital - Civic and General Campuses

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Iris Nguyen, BSc

613-798-5555pnguyen@ohri.ca

Principal Investigator:

Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • Syncope
  • Cardiac monitoring
  • Emergency Department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-12-30.