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

NCT05066347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2025-12-30

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Venkatesh Thiruganasambandamoorthy · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2027-07-30
Completion
2027-07-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066347 on ClinicalTrials.gov