Remote Cardiac Monitoring of Higher-Risk Emergency Department Syncope Patients After Discharge - A Pilot Study

Summary

2-3% of emergency department (ED) syncope patients suffer arrhythmia/death within 30 days of disposition (either as an inpatient or at home) and we have recently developed the Canadian Syncope Risk Score (CSRS) to predict these outcomes. Currently, only Holter monitoring is used and is applied a few days later. New and innovative remote (out-of-hospital) external cardiac monitoring technology has made prolonged monitoring possible.

The primary objective is to compare diagnostic yield (identification of arrhythmia that requires treatment) for the following two strategies among higher-risk syncope patients discharged home from ED: 15-day external cardiac monitoring (intervention arm) versus 48-hour Holter monitor (control arm)

Methods: The study will be a double-blind RCT comparing two different approaches for detecting serious arrhythmias among high-risk ED syncope patients who are discharged home. Cardiophone (live monitor) will be used for the intervention arm and the Mobile Cardiac Telemetry (MCT) device will be used for the control arm and both devices applied prior to ED discharge. For patient safety purposes and to ensure that the patients are similar in both arms, all of the study patients will be monitored for 15 days. MCT will function as a holder for the first 48 hours and this will be used to compare the diagnostic yield in the two study arms. After written informed consent, patients will be randomized 1:1 with allocation concealed by web-based randomization and stratified based on the total CSRS scores.

Data collection: patient demographics, medical history, score predictors, device data (failure, false alarms, duration worn), patient symptoms, and comfort. The primary outcome will be the diagnostic yield at 15 days in the two study arms and primary analysis will compare the diagnostic yield by intention to treat principle controlling for the stratification factor. Sample Size: 300 patients per arm (600 total) to detect a 10% difference in diagnostic yield between the arms.

Impact: Our study will increase the early identification of patients with serious underlying arrhythmia by combining the CSRS risk tool with innovative remote monitoring technology.

Conditions

• Syncope
• Arrhythmia

Interventions

DEVICE

Cardiophone

Remote live monitoring for 15 days for detection or exclusion of arrhythmias

Sponsors & Collaborators

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Venkatesh Thiruganasambandamoorthy, MBBS · Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-24

Primary Completion

2020-03-08

Completion

2020-04-08

Countries

• Canada

Study Locations