Mobile Cardiac Outpatient Telemetry for Unexplained Syncope

NCT05957315 | Unknown DMC FDA Device

• 1 other identifier: IRB-22-1733
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cardiac monitoring; Syncope; Unexplained syncope

Outcome Measures

Primary Outcomes (2)

• Time to arrhythmia diagnosis for unexplained syncope

  Comparison of time to arrhythmia diagnosis for intervention vs. control group

  1 month

• Time to medical intervention following unexplained syncope

  Comparison of time to medical intervention for intervention vs. control group

  1 month

Study Arms (2)

Mobile Cardiac Outpatient Telemetry Device (MCOT)

EXPERIMENTAL

These participants will be randomized into receiving the Philips/BioTel MCOT device in addition to usual care.

Device: Mobile Cardiac Outpatient Telemetry Device (MCOT)

Standard Treatment Group

NO INTERVENTION

These participants will be randomized into only receiving usual care and will not receive the MCOT device.

Interventions

Mobile Cardiac Outpatient Telemetry Device (MCOT) DEVICE

Application of a Philips/Biotel MCOT device

Also known as: cardiac monitor, cardiac monitoring, mobile cardiac telemetry

Mobile Cardiac Outpatient Telemetry Device (MCOT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED presentation for syncope or near syncope without identified cause of syncope during ED evaluation
• Willingness to enroll in the trial
• greater than or equal to 50 years of age
• cell phone coverage at their primary residence
• home or cell phone service for follow up calls
• ability to answer questionnaires without assistance
• English language speaker

You may not qualify if:

• unwillingness to participate in the study
• unable to consent on their own
• seizure as presumptive cause of loss of consciousness
• stroke, or transient ischemic attack as presumptive loss of consciousness
• loss of consciousness following head trauma
• confusion from baseline mental status (altered mental status)
• intoxication (alcohol or other drugs)
• medical or electrical intervention required to restore consciousness
• hypoglycemia as presumptive cause of loss of consciousness
• inability to provide follow up via telephone (phone that is not regularly in service)
• lack of permanent address (e.g. not a homeless shelter, half-way house, psychiatric treatment facility, or correctional facility)
• Lack of continuous cellular phone service with ATT, Verizon, or T-Mobile for MCOT relay
• known pregnancy
• Illiteracy

Sponsors & Collaborators

• Carilion Clinic: lead

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

Central Study Contacts

Andrew B Moore, MD

CONTACT

540-981-7000; abmoore1@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07