Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05957315 |
| Other study ID # |
IRB-22-1733 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
October 1, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Carilion Clinic |
| Contact |
Andrew B Moore, MD |
| Phone |
540-981-7000 |
| Email |
abmoore1[@]carilionclinic.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The study will establish the efficacy of ED-based, post-discharge mobile cardiac outpatient
telemetry for patients discharged with a diagnosis of unexplained syncope.
Research objectives are to 1) Measure the time to medical intervention in patients with
unexplained syncope fitted with a Philips MCOT at the time of hospital discharge compared to
patients treated with usual care for unexplained syncope; and 2) Measure the time to
arrhythmia diagnosis in patients with unexplained syncope fitted with a Philips MCOT at the
time of hospital discharge compared to patients treated with usual care for unexplained
syncope.
The hypothesis for this study is that participants who receive the Philips MCOT device upon
discharge will experience a shorter time to diagnosis for the cause of their episode of
syncope and receive subsequent medical intervention sooner than those who do not receive an
MCOT device.
Medical intervention is defined as a change in medical management, escalation of diagnostic
testing or device, or medical procedure that might result from diagnostic information
obtained from outpatient cardiac monitoring following a syncopal episode. Change in medical
management includes, but is not limited to, initiation of a new medication, lifestyle
modification recommendations, referral to medical specialist such as cardiology or
electrophysiology. Escalation of diagnostic device may include, but is not limited to,
ordering of diagnostic studies such as a cardiac stress test, echocardiogram, other cardiac
testing at the preference of the treating subspecialist, or placement of a longer duration
cardiac monitor such as an implantable loop recorder or cardiac event monitor. Medical
procedure is defined as cardiac pacemaker implantation, cardiac heart catheterization, or
other invasive cardiac procedure felt to be medically necessary by the treating specialist or
subspecialist physician.
An arrhythmia is an abnormal heart rhythm. In some instances syncope/near syncope, or
fainting/near fainting, may be the result of an undiagnosed abnormal heart rhythm. Abnormal
heart rhythms that might result in a fainting include atrial fibrillation, supraventricular
tachycardia, sinus pause, Mobitz Type II heart block, complete heart block, and ventricular
tachycardia. Wearing the mobile cardiac outpatient telemetry monitor increases the likelihood
of identifying fainting episodes that were caused by abnormal heart rhythms.
Previous studies are variable in the number and type of arrythmias captured that would
mandate medical intervention of some type that is measurable (medication, ablation, etc). All
comer diagnosis and absolute diagnosis of any arrythmia is much higher than 10%. Thus, we
based the pilot study size based on the lowest reported incidence in the literature for
arrythmias requiring a change in a patient's medical care of 10% as the lowest suspected
incidence for the Na sample size calculation. With a one-sided means test, 1-b at 0.80, and a
of 0.05, 8 events in Na requiring medical intervention of some type would be required to
demonstrate a 7d difference in time to intervention from the usual care group or 80 patients
in the Na and 160 total. The device manufacturer is providing up to 120 devices with
monitoring (up to 240 total study enrollees), which will allow for flexibility in the event
of loss to follow up or to increase power.
Study participants will be randomized at ED discharge into either the control group, which
receives usual care (referrals to follow up with outpatient services), or the experimental
group, which receives usual care AND are fitted with a Philips MCOT device and remotely
monitored for 30 days along with possible referrals to follow up with outpatient services.
Data will be collected from participants' medical records to determine whether additional
episodes of syncope or near syncope, diagnosis, and/or treatment occurred. Additionally,
participants will be contacted by the study team at 14 and 30 days post-discharge to answer
questions to determine whether additional episodes of syncope or near syncope occurred,
whether treatment occurred, and whether they complied with follow up referrals. To determine
if there is a difference in the time to medical intervention and in time to arrhythmia
diagnosis, we will conduct two-sample tests of proportions. Secondary outcome analysis will
be descriptive.
