SyncopeNCT05957315
Mobile Cardiac Outpatient Telemetry for Unexplained Syncope
A study testing Mobile Cardiac Outpatient Telemetry Device (MCOT) in people with Syncope and Arrhythmia, run by Carilion Clinic.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Syncope, Arrhythmia, Near Syncope
- What is being tested?
- Mobile Cardiac Outpatient Telemetry Device (MCOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mobile Cardiac Outpatient Telemetry for Unexplained Syncope: Time to Treatment, Arrhythmia Diagnosis and Outcome
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.
Read the detailed 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.
- Conditions
- Syncope, Arrhythmia, Near Syncope, Arrhythmias, Cardiac
- Being tested
- Mobile Cardiac Outpatient Telemetry Device (MCOT)
- Keywords
- Cardiac monitoring, Syncope, Unexplained syncope
- Medical subject headings
- Syncope, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Cardiac Outpatient Telemetry Device (MCOT)Device
Also called cardiac monitor, cardiac monitoring, mobile cardiac telemetry
Application of a Philips/Biotel MCOT device
| Study group | Role | What they receive |
|---|---|---|
| Mobile Cardiac Outpatient Telemetry Device (MCOT) | Experimental | These participants will be randomized into receiving the Philips/BioTel MCOT device in addition to usual care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to arrhythmia diagnosis for unexplained syncope
Comparison of time to arrhythmia diagnosis for intervention vs. control group
Measured: 1 month
Time to medical intervention following unexplained syncope
Comparison of time to medical intervention for intervention vs. control group
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Moore, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957315
- Sponsor's protocol ID
- IRB-22-1733
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cardiac Outpatient Telemetry for Unexplained Syncope: Time to Treatment, Arrhythmia Diagnosis and Outcome
- ClinicalTrials.gov ID
- NCT05957315
- Acronym / sponsor ID
- IRB-22-1733
- Conditions
- Syncope, Arrhythmia, Near Syncope, Arrhythmias, Cardiac
- Keywords
- Cardiac monitoring, Syncope, Unexplained syncope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Cardiac Outpatient Telemetry Device (MCOT) | Experimental | Device: Mobile Cardiac Outpatient Telemetry Device (MCOT)These participants will be randomized into receiving the Philips/BioTel MCOT device in addition to usual care. |
| Standard Treatment Group | No intervention | –These participants will be randomized into only receiving usual care and will not receive the MCOT device. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Cardiac Outpatient Telemetry Device (MCOT)Also: cardiac monitor, cardiac monitoring, mobile cardiac telemetryApplication of a Philips/Biotel MCOT device | Device | Mobile Cardiac Outpatient Telemetry Device (MCOT) |
Primary outcome
Time to arrhythmia diagnosis for unexplained syncope
Time frame: 1 month
Comparison of time to arrhythmia diagnosis for intervention vs. control group
Time to medical intervention following unexplained syncope
Time frame: 1 month
Comparison of time to medical intervention for intervention vs. control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Cardiac Outpatient Telemetry Device (MCOT) in people with Syncope and Arrhythmia, run by Carilion Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew B Moore, MD (540-981-7000, abmoore1@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to arrhythmia diagnosis for unexplained syncope (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.