Neuralert Stroke Monitor Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 主要终点
- Efficacy of Device
研究概览
简要总结
The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring and expedited recognition of stroke by identifying asymmetry in the extremities, facilitating patient treatment and improving outcomes. This study is designed to evaluate the safety and effectiveness of the Neuralert Monitor. This study aims to show that the device produces fewer than 2 false alarms per patient per day on average, and that the device detects stroke with a sensitivity significantly greater than a device producing 2 random alerts per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(all must be yes)
- •Male or female age ≥ 22 years
- •Admitted or planned admission to one of the participating hospitals and followed by the Cardiothoracic (CT) Surgery or Vascular Surgery services
- •Considered at high risk for stroke while in the hospital based on:
- •Interventions or procedures that are high-risk for stroke performed during the hospitalization, which may include:
- •Intracardiac surgical or endovascular procedures, including valve replacement
- •Ascending aorta or aortic arch surgical or endovascular repair
- •Open surgical or endovascular carotid revascularization
- •Other cardiac procedures along with a high-risk medical history:
- •Age ≥ 80 years
- •Prior stroke/ transient ischemic attack (TIA)
- •Hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation
- •Severely reduced left ventricular cardiac ejection fraction (i.e., <30%) or anterior left ventricular wall akinesis
- •Atrial fibrillation
排除标准
- •(all must be no)
- •Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- •Baseline preoperative asymmetric upper extremity weakness as assessed by the Investigator, defined as a differential in the NIHSS upper extremity motor score between the two arms of >0
- •Above the wrist amputation
- •Unwilling to provide informed consent or no legally authorized representative willing to provide consent if the patient is unable
- •Currently imprisoned
研究组 & 干预措施
Cardiac Surgery Patients
Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke.
干预措施: Neuralert Monitor (Device)
结局指标
主要结局
Efficacy of Device
时间窗: through study completion, an average of 2 years
To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and
Safety of Device
时间窗: through study completion, an average of 2 years
To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal.
次要结局
- Length of time to detection of any stroke(through study completion, an average of 2 years)
- Length of time to detection of stroke by Neuralert(through study completion, an average of 2 years)
- Number of alerts caused by stroke (PPV)(through study completion, an average of 2 years)