Mobile Cardiac Outpatient Telemetry for Unexplained Syncope: Time to Treatment, Arrhythmia Diagnosis and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Time to arrhythmia diagnosis for unexplained syncope
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time to arrhythmia diagnosis for unexplained syncope
时间窗: 1 month
Comparison of time to arrhythmia diagnosis for intervention vs. control group
Time to medical intervention following unexplained syncope
时间窗: 1 month
Comparison of time to medical intervention for intervention vs. control group
次要结局
未报告次要终点
研究者
Andrew Moore
Principal Investigator
Carilion Clinic