Stroke Alarm Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 500
- 试验地点
- 14
- 主要终点
- Time from onset of stroke with unilateral arm motor deficit until alarm by the device.
研究概览
简要总结
The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset.
This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.
A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size.
Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study.
Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:
- recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR
- recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR
- atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR
- recent hemorrhagic stroke with atrial fibrillation, without persisting arm motor deficit The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.
A control population matched for calendar year, age (± 5 years), sex, healthcare region, baseline stroke severity according to the National Institutes of Health Stroke Scale (NIHSS, ± 5 points), unilateral arm motor deficit (NIHSS item 5a/5b 1-4), presence of neglect/inattention (NIHSS item 11 1-2), atrial fibrillation, cohabitation status and pre-stroke functional level twill be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.
详细描述
Objectives and hypotheses of the clinical investigation The aim of this study is to test the ability and efficacy of the CE-marked wearable system Stroke Alarm to detect a stroke onset early.
The hypothesis is that the Stroke Alarm is able to indicate at least 60% of stroke cases with unilateral arm motor deficit within 3 hours of onset with a specificity of at least 80%.
Design of the clinical investigation This is a prospective single arm observational trial with a propensity-matched registry-derived control group.
All patients with a diagnosis of stroke (ischemic stroke or intracerebral hemorrhage) without arm motor deficits, TIA or atrial fibrillation at the participating hospitals that fulfill all inclusion critera and no exclusion criteria is asked for participation in the trial.
The patient is after the setup wearing the device continuously for three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 50 years or older
- •Modified Rankin scale of 0-
- •Diagnosed with either:
- •A. Recent* transient ischemic attack (TIA, G45.9), AND:
- •ABCD2 score of ≥6, OR:
- •Atrial fibrillation OR:
- •Large artery atherosclerosis**.
- •B. Recent* acute ischemic stroke (I63), AND:
- •Atrial fibrillation, OR:
- •Large artery atherosclerosis**. C. Atrial fibrillation/flutter (I48), AND
- •None, or reduced dose of, oral anticoagulation medication***, AND
- •CHA2DS2-VASC score ≥
- •D. Recent* intracerebral hemorrhage (I61.9), AND:
- •Atrial fibrillation.
- •The patient has received the required information about the study and agrees in writing to participate.
- •Smartphone user since at least 1 year.
- •Within the last 2 weeks **Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.
- •Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.
排除标准
- •Previous inclusion in this study.
- •Arm motor deficit from any previous medical condition.
- •Unable to give informed consent to participate in the study.
- •Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.
- •Does not have access to a Stroke Alarm compatible smartphone.
- •Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.
- •Does not want to participate.
研究组 & 干预措施
Stroke Alarm use
The patients are provided with Stroke Alarm and instructed to use it in accordance with the IFU for a 3 months period.
干预措施: Stroke Alarm (Device)
结局指标
主要结局
Time from onset of stroke with unilateral arm motor deficit until alarm by the device.
时间窗: An alarm generated within 3 hours following onset of stroke with unilateral arm paresis
The alarm is recorded systematically from the device backend. The ground truth is gathered based on the medical records for stroke events during the study period. Pre-set definitions are defined what is considered a true positive, a false positive, a true negative and a false negative.
Alarm from device within 3 hours of onset of stroke with unilateral arm motor deficit.
时间窗: From enrollment to the end of treatment at 3 months
The alarm is recorded systematically from the device backend. The ground truth is gathered based on the medical records for stroke events during the study period.
次要结局
- Time from onset of stroke with unilateral arm motor deficit until alarm by device.(From enrollment to the end of treatment at 3 months)
- Time from onset of stroke with unilateral arm motor deficit until arrival to first hospital.(From enrollment to the end of treatment at 3 months.)
- Number of alarms indicated by the device within 3 hours of onset, in patients with a subsequent clinical diagnosis of stroke.(From enrollment to the end of treatment at 3 months.)
- Number of alarms indicated by the device within 3 hours of onset, in patients with a subsequent clinical diagnosis of a stroke mimic.(From enrollment to the end of treatment at 3 months.)
- Number of IVT and/or EVT treatments.(From enrollment to the end of treatment at 3 months)
- Number of complications/adverse events generated by the device.(From enrollment to the end of treatment at 3 months)