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| Name | Class |
|---|---|
| Wayne State University | OTHER |
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Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINDRHYTHM HARMONY | Passive Recording of the head pulse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmony | Device | Passive recording of the head pulse |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. | The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the "ground truth" diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions). | Through study completion, an average of 6 months |
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Inclusion Criteria:
• suspected stroke in the prehospital setting
Exclusion Criteria:
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Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
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| Name | Affiliation | Role |
|---|---|---|
| James Paxton, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne Health | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31591693 | Background | Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x. |
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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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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |