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

NCT02786940 | Completed DMC

• 1 other identifier: 20160119-01H
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

remote; cardiac monitoring; mortality

Outcome Measures

Primary Outcomes (1)

• Proportion of participants among whom arrhythmias are detected that required treatment

  The primary outcome will be the diagnostic yield and includes detection of serious arrhythmias that required treatment or that caused death. The investigators will collect data on the type of treatment offered (medications; implantable loop recorder, pacemaker, defibrillator, or dual device insertions; cardioversion or therapeutic ablation). A blinded Adjudication Committee of 3 physicians will confirm all outcomes.

  15-days

Secondary Outcomes (4)

• Exclusion of arrhythmia

  15-days

• Detection of arrhythmias that did not require treatment

  15 days

• Safety of the live monitoring device

  15 days

• Compliance of the participants in wearing the devices

  15 days

Study Arms (2)

Live Remote Cardiac Monitoring

EXPERIMENTAL

Patients in this arm will receive the Cardiophone device, a live remote cardiac monitoring with transmission of cardiac rhythm (device-triggered: if rhythm abnormalities detected by device algorithm; or patient-triggered by pressing the transmit button because of symptoms) for 15 days.

Device: Cardiophone

Usual Care

ACTIVE COMPARATOR

Patients in this arm will receive the Mobile Cardiac Telemetry device for 48-hour Holter monitoring as part of usual care. This device combines holter, event monitoring and mobile cardiac telemetry (continuous cardiac monitoring of every single beat) into one unit. The holter functionality will be used for the first 48 hours (usual care). The diagnostic yield from the 48 hour holter monitoring will be compared to the 15-day live monitoring.

Device: Cardiophone

Interventions

Cardiophone DEVICE

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

Also known as: ER920W event recorder, Braemar Inc

Live Remote Cardiac Monitoring; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥18 years) patients with syncope
• High-risk as per the Canadian Syncope Risk Score (score \> or =3)and being discharged home after ED physician or consultant assessment.

You may not qualify if:

• Syncope patients with a score \<3
• Those who are hospitalized
• Previously enrolled.
• Loss of consciousness not related to syncope: prolonged loss of consciousness \> 5 minutes
• Change in the mental status from baseline
• Patients with alcohol intoxication or illicit drug abuse, witnessed obvious seizure; or head trauma, i.e. trauma the initial event.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Syncope; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Venkatesh Thiruganasambandamoorthy, MBBS

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: June 1, 2016
• Study Start: October 24, 2016
• Primary Completion: March 8, 2020
• Study Completion: April 8, 2020
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)