Ischemic Conditioning During Air tRansport Save penUmbral Tissue (ICARUS)

Enrique Leira

Status: Enrolling

Conditions: Acute Stroke

Treatments: Device: Ischemic conditioning device

Study type: Interventional

Funder types: Other

Identifiers

NCT03481205

201712791

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥18 and ≤ 80 years
2. Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
3. Patient screened for rtPA, and rtPA administered if eligible
4. Subject or legally authorized representative able to provide consent at the time of the assessment
5. NIHSS 6-20

Exclusion criteria

1. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
2. History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
3. History of diabetes mellitus
4. Enrollment in another clinical trial
5. Patient incarcerated
6. Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
7. Agitation deemed unsafe for ischemic preconditioning testing.
8. Arteriovenous fistula in upper limb

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ischemic Conditioning

Experimental group

Description:

Doctormate device used en route to the comprehensive stroke center

Treatment:

Device: Ischemic conditioning device