Long-term Cardiac Monitoring After Cryptogenic Stroke (CMACS): A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Completion of Clinical Follow-up as a Measure of Feasibility
研究概览
简要总结
Atrial fibrillation (AF) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. Patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding AF. Small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of AF. However, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of AF than routine clinical follow-up. The investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. The investigators will enroll 40 consecutive adult patients seen at the University of California at San Francisco (UCSF) Neurovascular service with cryptogenic stroke or high-risk TIA (ABCD2 score 4 or greater). Enrolled patients will be randomized in a 1:1 fashion. Group A will be assigned to wear an ambulatory cardiac event monitor for 21 days. Group B will be discharged home without a monitor and will serve as controls during routine clinical follow-up. The investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. The investigators' secondary outcomes will be diagnoses of AF at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA
- •Onset of stroke or TIA symptoms within the previous 60 days
排除标准
- •Definite small-vessel etiology by history or imaging
- •Source found on vascular imaging of possible culprit vessels
- •Source found by echocardiography (TEE not required)
- •History of atrial fibrillation
- •Atrial fibrillation on admission ECG
- •Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required)
- •Obvious culpable systemic illness such as endocarditis
- •Patient unable to provide written, informed consent
结局指标
主要结局
Completion of Clinical Follow-up as a Measure of Feasibility
时间窗: 1 year
Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable
Completion of Assigned Monitoring as a Measure of Feasibility
时间窗: 21 days
Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.
次要结局
- Diagnosis of Atrial Fibrillation(1 year)
- Recurrent Stroke or TIA(1 year)
