UnknownNot Applicable

Mobile Cardiac Outpatient Telemetry for Unexplained Syncope

160 participantsStarted 2023-09-01

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to arrhythmia diagnosis for unexplained syncope

Timeframe: 1 month

Time to medical intervention following unexplained syncope

Timeframe: 1 month

Trial details

NCT IDNCT05957315

SponsorCarilion Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Andrew B Moore, MD

540-981-7000 abmoore1@carilionclinic.org

View on ClinicalTrials.gov More Syncope trials