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The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.
In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.
The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.
Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.
The study will be conducted at one site ( University of Iowa Hospitals and Clinics)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic Conditioning | Experimental | Doctormate device used en route to the comprehensive stroke center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischemic conditioning device | Device | RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the feasibility of delivering RLIC by air medical crews in patients with AIS. This will be assessed by recording the number of cycles completed during transport. | Feasibility will be assessed based on the number of cycles performed during transportation by air as follows: For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC. For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC. For flight duration of < 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC. | The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Assess adverse events related to performing RLIC in patients with large vessel occlusion. | We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events | AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Shaban, MD | Contact | 3193568755 | amir-shaban@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Enrique Leira, MD | University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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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 |