RecruitingNot ApplicableNCT05066347

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

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

Sponsor

Ottawa Hospital Research Institute

Enrollment

580 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Syncope

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether using a remote cardiac monitor (a small wearable or implantable device) to continuously track heart rhythm after an emergency department (ED) visit for fainting (syncope) leads to better detection of dangerous heart arrhythmias and better patient outcomes compared to standard follow-up care. You may be eligible if: - You are 18 years or older - You came to the emergency department with a fainting episode within the past 24 hours - You were assessed as medium or high risk based on a cardiac syncope scoring tool (CSRS score of 3 or above) - You are being discharged from the emergency department You may NOT be eligible if: - You were unconscious for more than 5 minutes - Your Glasgow Coma Scale score was below 15 (unless you have dementia) - There was a witnessed seizure or head injury just before losing consciousness - You were intoxicated or unable to give an accurate history - You were admitted to the hospital for a serious condition causing the fainting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardiophone 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.