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Mobile Cardiac Outpatient Telemetry for Unexplained Syncope

NCT05957315 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-07-24

No results posted yet for this study

Summary

This study seeks to provide evidence that use of Philips mobile cardiac outpatient telemetry (MCOT) devices may improve patient care for patients who present to emergency departments (EDs) with syncope, which is a temporary loss of consciousness also known as fainting or who present experiencing a near temporary loss of consciousness (near syncope). It is set up as a random controlled trial, which means research participants will be randomly assigned to receiving the device or usual care. Patients 50 years or older who come to the ED of Carilion Roanoke Memorial Hospital will be screened by study team members for unexplained syncope or near syncope across three ED dispositions: hospital admission, emergency department clinical decision unit admission (ED CDU) and emergency department. After consent, subjects will be enrolled and randomized, via REDCap randomization, in the study. At the time of subject discharge the MCOT device will be placed on the chest for the arm of intervention patients (for subjects who were admitted, the research study team will follow the patient's clinical course and placement of the device will occur at discharge); subjects will also receive brief instruction on the care and maintenance of the device and a patient education guide. The research team will contact the subjects for a telephone follow up at 14 and 30 days post-enrollment. The study will establish the efficacy of mobile cardiac outpatient telemetry in comparison to observation telemetry. Research objectives are to 1) Measure the time to medical intervention in patients with unexplained syncope or near syncope fitted with a Philips MCOT at the time of hospital discharge compared to patients treated with usual care for unexplained syncope or near syncope; and 2) Measure the time to arrhythmia diagnosis in patients with unexplained syncope or near syncope fitted with a Philips MCOT at the time of hospital discharge compared to patients treated with usual care for unexplained syncope or near syncope.

Conditions

  • Syncope
  • Arrhythmia
  • Near Syncope
  • Arrhythmias, Cardiac

Interventions

DEVICE

Mobile Cardiac Outpatient Telemetry Device (MCOT)

Application of a Philips/Biotel MCOT device

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Device
Yes

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Entities

Diseases

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 NCT05957315 on ClinicalTrials.gov