REmote Cardiac MOnitoring of At-risk SYNCope Patients After Emergency Department Discharge - A Multicenter Randomized Controlled Trial: REMOSYNCED

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
Canada
The Ottawa Hospital - Civic and General Campuses
Recruiting
Ottawa
Contact Information
Primary
Bahareh Ghaedi, MSc, CCRA
bghaedi@ohri.ca
613-823-1299
Backup
Phuong Anh (Iris) Nguyen, BSc
pnguyen@ohri.ca
613-823-1299
Time Frame
Start Date: July 1, 2022
Estimated Completion Date: July 30, 2026
Participants
Target number of participants: 426
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov

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