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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Surgery Patients | Experimental | Device: Neuralert Monitor Device to identify upper extremity asymmetry in patients who are high risk for stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuralert Monitor | Device | The Neuralert monitoring system, a non-invasive device worn on each wrist, is designed to provide continuous monitoring for asymmetry in the extremities, sending an alert to healthcare workers upon identification, thus expediting recognition of stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Device | To show that the sensitivity of the Neuralert Monitor exceeds the specified performance goal, and | through study completion, an average of 2 years |
| Safety of Device | To show that the mean number of false alarms/patient/day for the Neuralert Monitor is less than the specified performance goal. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Length of time to detection of any stroke | Time from last known normal to detection of any stroke with weakness | through study completion, an average of 2 years |
| Length of time to detection of stroke by Neuralert |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of causes of false alarms | A false alarm is defined as any alarm that does not result in a clinical diagnosis of stroke after the next evaluation by the clinical team | through study completion, an average of 2 years |
| Sensitivity of device |
Inclusion Criteria: (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:
Other cardiac procedures along with a high-risk medical history:
Exclusion Criteria: (all must be no)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett Cucchiara, MD | Contact | (215) 662-6738 | cucchiar@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36718858 | Background | Messe SR, Kasner SE, Cucchiara BL, McGarvey ML, Cummings S, Acker MA, Desai N, Atluri P, Wang GJ, Jackson BM, Weimer J. Derivation and Validation of an Algorithm to Detect Stroke Using Arm Accelerometry Data. J Am Heart Assoc. 2023 Feb 7;12(3):e028819. doi: 10.1161/JAHA.122.028819. Epub 2023 Jan 31. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Time from last known normal to detection by the Neuralert Monitor of any stroke with weakness
| through study completion, an average of 2 years |
| Number of alerts caused by stroke (PPV) | How often an alert is caused by confirmed stroke | through study completion, an average of 2 years |
Sensitivity of device for detection of any stroke, regardless of whether the stroke includes asymmetric weakness
| through study completion, an average of 2 years |
| Number of care visits | Number of usual care visits documented in the electronic health record | through study completion, an average of 2 years |
| Number and type of adverse events | Any adverse events collected during the study | through study completion, an average of 2 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |