REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge -RCT (REMOSYNCED)
Syncope
About this trial
This is an interventional diagnostic trial for Syncope focused on measuring Syncope, Cardiac monitoring, Emergency Department
Eligibility 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
Sites / Locations
- The Ottawa Hospital - Civic and General CampusesRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Usual care
Prolonged 24/7 live outpatient cardiac rhythm monitoring
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).
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.